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Dr. js barrett, cv_oct2008

CURRICULUM VITAE
JEFFREY S. BARRETT, Ph.D., FCP
PERSONAL INFORMATION
Business Address: The Children's Hospital of Philadelphia Abramson Research Center, Rm 916H 34th Street and Civic Center Boulevard Philadelphia, PA 19104-4318 EDUCATION

1986 - 1990

1981 - 1986

ACADEMIC APPOINTMENTS AND AWARDS
10/03 – present
Research Associate Professor, Pediatrics, The University of Pennsylvania, School of Medicine Associate Scholar, Center for Clinical Epidemiology and Biostatistics, The University of Pennsylvania, School of Public Health Adjunct Appointment, the University of Tennessee, School of Pharmacy, Department of Pharmaceutics: Adjunct Associate Professor Adjunct Appointment, the University of Florida, School of Pharmacy, Department of Pharmaceutics: Adjunct Professor Adjunct Appointment, the University of South Florida, School of Medicine, Department of Pharmacology: Clinical Assistant Professor Psi Kappa Epsilon Honorary Chemical Society H. Helfman Pharmacy Student Fellow, University of Michigan J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PROFESSIONAL EXPERIENCE

4/03 – present
Research Associate Professor, Pediatrics, University of Pennsylvania Associate Scholar, Clinical Epidemiology and Biostatistics Director, Laboratory for Applied PK/PD The Children's Hospital of Philadelphia 34th Street and Civic Center Boulevard Philadelphia, PA 19104-4318 Currently the Principal Investigator for the CHOP Pediatric Pharmacology Research Unit (PPRU) and the Director of the Penn/CHOP Kinetic Modeling and Simulation (KMAS) core of the CTSA. Research is focused on the investigation of sources of variation in pediatric pharmacokinetics. Applied clinical pharmacologic investigation coupled with modeling and simulation strategies are pursued with the intention of developing rational dosing guidance in various pediatric populations for both marketed and exploratory compounds. Clinical trial simulation is utilized prospectively to explore design dependencies and parameter sensitivities. The Laboratory for Applied PK/PD is focused on the development of novel pharmacometric approaches, biomarker development and disease progression modeling. Aventis Pharmaceuticals Route 202-206, P.O. Box 6800 Managed 13 scientists worldwide to support late stage development (Phase IIb through post marketing) with an annual budget of $25 million Euro. Responsibilities included the conduct and regulatory submission preparation of definitive clinical bioavailability and bioequivalence and related manufacturing specification studies, formulation development and screening trials, population pharmacokinetics, late stage drug interaction and special population studies, and mechanistic PK characterization. Represented the DMPK Department on both Leads Optimization (LO) and Product Realization (PR) leadership teams, the PR operating review committee, and various global pharmacokinetics methods coordination teams. Co-chaired DMPK-IS Data Warehouse and Modeling & Simulation project teams. Steering Committee member for Modeling & Simulation effort. J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PROFESSIONAL EXPERIENCE (con’t)

11/00 – 4/01
Directed the Clinical PK effort in support of the cardiovascular and CNS franchises as well as the IT support of the DM&PK department. Conduct preclinical and clinical aspects of drug development including bioanalytical, toxicokinetic, pharmacokinetic, and pharmacodynamic support. Functional responsibilities include protocol design, toxicokinetic, pharmacokinetic, pharmacodynamic analyses and reporting for pre-NDA and NDA development stages, FDA liaison, and bioanalytical site selection. Supervisory responsibilities include the management of 3 PhD scientists, 1 web-programmer, 1 data warehouse administrator, and 2 junior staff scientists. Co-authored population pharmacokinetic analysis reports for Sustiva and innohep NDAs. Co-authored Biopharmaceutics Sections for Morphine Sulfate CR ANDA and innohep NDA. Initiated data warehousing efforts for department including intranet-based access and exploitation tools. Developed novel biomarkers for Factor Xa inhibitor program. Company representative for co-development of SAS PH-Kinetics non-compartmental pharmacokinetic analysis application. Departmental representative for R&D Bioinformatics initiative. Conduct preclinical and clinical aspects of drug development, contract all bioanalytical and clinical services, supervise database management of post marketing and ongoing clinical drug safety surveillance programs, develop flexible data entry system for monitoring of clinical laboratory and adverse event data from ongoing development programs, and provide hardware and software support for the Somerset PC network. Functional responsibilities include protocol design, study monitoring, toxicokinetic, pharmacokinetic, pharmacodynamic and statistical analyses and reporting, FDA liaison, clinical and bioanalytical site selection, the management of all R&D computer resources, and supervision of six people (pharmacokineticist, statistician, programmers, CRAs). Completed numerous Phase-I studies in healthy male volunteers, healthy elderly men and women, post-menopausal women, and SDAT patients in support of the selegiline transdermal system and ipriflavone development programs and product line extensions for Eldepryl. Authored Biopharmaceutics Section for Eldepryl Capsule ANDA. Completed acute, subacute and chronic toxicology studies, in vitro topical metabolism, and pharmacology studies in support of the selegiline transdermal system and ipriflavone development programs. J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PROFESSIONAL EXPERIENCE (cont.)
8/90 - 3/94
Conducted the human aspects of ethical drug development in areas of metabolism, pharmacokinetics, pharmacodynamics, and bioanalysis in MRL Drug Metabolism Department. Responsible for fibrinogen receptor antagonist, oxytocin antagonist, growth hormone secretagogue programs, defense of Vasotec® and Pepcid® AC product lines. Co-author of Pepcid® AC NDA. Co-author of NM-Win algorithm (front-end to NONMEM). Founded Mid-Atlantic Population Approach Methods Users Group. Eastern Michigan University Corporate Services Designed and interpreted experiments in various manufacturing processes (foam engineering and magnetic gage group) and instructed SPC (statistical process control) to employees at Ford Motor Company. Teaching Assistant - Biostatistics (regression analysis)
HONORS AND AWARDS
1996
Accomplishment Award for Morphine Sulfate simulations and recommendation for study designs Accomplishment Award for innohep NDA Accomplishment Award for innohep Advisory Board Presentations Accomplishment Award for preclinical collaborations with Loyola University on innohep PK/PD PhRMA Clinical Committee Appreciation Award for Leadership on PhRMA Expert Panel on Individual and Population Bioequivalence Elected ACCP Fellow Accomplishment Award for innohep pharmacy and nursing board presentations Accomplishment Award for medical affairs training on innohep pharmacology, PK, and PD Accomplishment Award for Surrogate Marker Symposium organization Recognition Award for Leadership of Clinical Pharmacology and Translational Research (CPTR) Section of AAPS Bristol Myers Squibb Mentorship Award in Clinical Pharmacology, ACCP J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

SCIENTIFIC COMMITTEE SERVICE


DuPont Pharmaceuticals DM&PK Safety Committee Chairman, 1997 DuPont Pharmaceuticals DM&PK Awards Committee, 1997 DuPont Pharmaceuticals DM&PK Representative to Delaware Valley Drug Metabolism Discussion Group (DMDG), 1997 - 2001 Webmaster for Delaware Valley Drug Metabolism Website (DVDMDG.org), 1997-8 Chair, Delaware Valley Drug Metabolism Discussion Group, 1998 - 2000 FDA Expert Panel Member on Individual and Population Bioequivalence (Blue-Ribbon Panel) Advisory Board, AAPS Bioequivalence Focus Group Scientific Advisory Board, Innaphase Corporation, 1998 - 2004 DM&PK representative on PhRMA Expert Panel: Individual and Population Bioequivalence Guidance (Red-ribbon Panel) Chair, AAPS/PPDM PK/PD Software Evaluation Group, 2000-2001 Program Committee ACCP Annual Meeting, 2002-2003 National Advisory Board, University of Florida College of Pharmacy, 2002-present Vice-Chair / Chair, Clinical Sciences Section, AAPS, 2003-2006 Therapeutic Standards Committee, The Children's Hospital of Philadelphia, 2003-present Clinical Pharmacology Advisory Committee, Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, 2004-present Modeling and Simulation Application in Clinical Therapeutics (MoSAIC) Steering Committee, 2005-present Board of Directors, Metrum Research Institute, 2006-present Program Committee, 19th ACCP Frontiers Symposium: “Innovative Approach for Early Drug Development – Disease Models and Novel Trial Design” Baltimore, MD, May 1, 2007 Therapeutic Drug Monitoring Section Chair, American Society of Clinical Pharmacology & Therapeutics, 2008-11 AAPS Member at Large (Board of Directors), 2008-2011
PROFESSIONAL AFFILIATIONS AND ACTIVITIES

American Association of Pharmaceutical Scientists (AAPS) Delaware Valley Drug Metabolism Discussion Group American Society of Clinical Pharmacology and Therapeutics (ASCPT) American Society for Pharmacology and Experimental Therapeutics (ASPET) American College of Clinical Pharmacology (ACCP) East Coast Population Approach Users Group Modeling and Simulation Application in Clinical Therapeutics (MoSAIC) J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ONGOING RESEARCH SUPPORT

NIH U01, HD037255-06 (PI: Barrett)
NIH / NICHD, Pediatric Pharmacology Research Unit The major goals of this project are to facilitate and promote pediatric labeling of new drugs or drugs already on the market. The overall goal of the PPRU Network is the safe and effective use of drugs in children. The PPRU Network (1) conducts studies on the pharmacokinetics and pharmacodynamics of drugs in children, (2) provides a locus for pre- and post-marketing clinical trials in children conducted by pediatric clinical pharmacologists in collaboration with the pharmaceutical industry and contract research organizations, and (3) serves as an advisory body to the pharmaceutical industry, regulatory agencies, health professionals and the public on the appropriate use of drugs in children. NIH U01, CA098543-02S1 (PI: Reaman) NIH / NCI, Actinomycin-D/Vincristine Exposure-response in children with cancer The project pursues the clinical investigation of actinomycin-D and vincristine in children with cancer as a subcontract to the Children’s Oncology Group (COG) award. The project goals include a data mining effort to establish relationships between exposure and clinical outcomes in children diagnosed with Wilm’s tumor or rhabdomyosarcoma, the establishment of a procedure to both dose and draw blood for drug assay from a single central venous catheter, population-based pharmacokinetic modeling effort to define the sources of variation in subpopulations receiving vincristine and actinomycin-D and a prospective clinical trial utilized to (a) refine such a model, (b) explore pharmacogenetic sources of variation, (c) confirm relationships established between exposure and clinical outcomes and (d) derive dosing rules suitable for labeling. NIH R01 (PI: Schulman) NIH/NIMH, Pediatric Off-Patent Drug Study (PODS) Center- Sodium Nitroprusside This project involves the design, analysis and conduct of two trials investigating sodium nitroprusside in pediatric patients based on BPCA initiatives for exploring pharmacotherapy of poorly defined agents used extensively in pediatric populations. The specific aims of the first trial are (1) to define the onset and offset of blood pressure lowering effects of nitroprusside in order to obtain adequate instructions for dose titration and (2) to construct a pharmacokinetic/pharmacodynamic model that defines the relationship between nitroprusside infusion rate and changes in blood pressure. This investigation will also focus on the laboratory support of parent sodium nitroprusside and metabolite exposure in various biologic matrices (i.e., plasma and urine) and PK/PD and population-based modeling in support of the study objectives. NIH P01 MH076388 (PI: Douglas) NIMH / NAID, Neurokinin1-R antagonists for HIV therapy The goal of this Integrated Preclinical/Clinical Program (IPCP) is to identify an NK-1R antagonist that is: (a) active as an anti-HIV agent through interaction with chemokine/cytokine receptors (Project 1); (b) is specific for chemokine and G-protein coupled receptors (Project 2); (c) is safe for use in SIV-infected non-human primates and provides proof of concept related to antiviral, immunomodulatory, and neurobehavioral effects (Project 3); and, (d) is safe in humans and has positive immunomodulatory effects (Project 4). All projects contribute to understanding the basic virologic, molecular and cellular immunologic mechanisms of SP, NK-1R antagonists, and HIV/SIV infection. J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ONGOING RESEARCH SUPPORT con’t

1U54 RR023567-01
NCRR, Institutional Clinical and Translational Science Award The major goals are a) integration of the efforts of the partner institutions, including eight schools in Penn, to develop an interdisciplinary approach to clinical and translational science; b) expansion and inter-institutional development of ITMAT to assume the role of the “academic home” for clinical and translational science envisaged in the CTSA; c) the attendant development of new Centers, new cores and multiple new educational programs within ITMAT; d) the development of focused strategic alliances with the FDA, the Pharma and Computing industries, and the State to foster clinical and translational science; and d) the enhancement of medical practice and patient involvement in clinical and translational research. NIH U01 AT003573 (Reddy) Phase I/II Trials of Silymarin for Chronic Liver Diseases Two trials (Phase IB and Phase IIa trials) are proposed to provide guidance for the use of silymarin HCV patients The specific aims of the these trials are: (1) to determine the safety, tolerability and pharmacokinetics of a single oral dose administration of Sm relative to placebo in HCV patients non-responsive to Ifα, (2) to evaluate the therapeutic role of various doses of Sm compared to placebo in HCV patients by assessing parameters of liver injury (alanine aminotransferase [ALT]), (3) to evaluate the mechanism of Sm in the above cohort by studying the dose response effect of Sm on oxidative stress (OS) markers, immunological and virological responses, and viral kinetics and (4) to define rational dosing criteria constructed from exposure-response relationships based on Pharmokinetic/Pharmodynamic (PK/PD) modeling LLS SCOR 7372-07 (Felix) Targeted Therapies for Infant Leukemias
The objective of this program project is to improve the outcome of acute leukemia in infants. The
projects and core facilities are united by the central theme of identifying new drug targets in acute
leukemia in infants.
COMPLETED

Solvay Inc. (PI: Mascarenhas)
Malabsorption Blood Test: A Novel Approach to Quantify Steatorrhea The goals of the project is to develop a malabsorption blood test, using two odd chained fatty acids, that will replace the 72-hour stool collection as a more acceptable, accurate and precise assessment of fat malabsorption in subjects with pancreatic insufficiency (including CF). Modeling and simulation techniques are utilized to define the conditions of the test and partition sources of variation among patient subpopulations in support of product labeling. J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

MENTORING / ADVISORY EXPERIENCE

Training
Training Type of Research Project
Current Position/
Current Support
Windows interface to NONMEM, President, “NM-Win” Clinical pharmacology, modeling, Senior Scientist, Clinical pharmacology, modeling, Associate Director, Oncology Clinical pharmacology, modeling, Assistant Professor, CHOP simulation Clinical pharmacology, modeling, Principal Scientist, Genentech Clinical pharmacology, modeling, US FDA, Office of Clinical Clinical pharmacology, modeling, Post doctoral Candidate, CHOP Clinical pharmacology, modeling, Post doctoral Candidate, CHOP Clinical pharmacology, modeling, Post doctoral Candidate, CHOP Clinical pharmacology, modeling, Post doctoral Candidate, CHOP J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

INVITED PRESENTATIONS
1.
“Kinetics and Bioavailability/Bioequivalence”. Presented at Pharmaceutical Manufacturers Association Education and Research Institute’s Annual Training Course for Nonclinical Statisticians Meeting, Georgetown University, Washington, D.C., February 28 - March 2, 1993. “Pharmacodynamics”. Presented at Pharmaceutical Manufacturers Association Education and Research Institute’s Annual Pharmacology Training Course: Track C Pharmacokinetics, Georgetown University, Washington, D.C., September 28-30, 1993. “Pharmacodynamics”. Presented at Pharmaceutical Manufacturers Association Education and Research Institute’s Pharmacokinetics Course, Philadelphia, March 6-8, 1994. “Pharmacokinetics and Pharmacodynamics”, Lectures 1-3 in NGR 6199, Pharmacology for Advanced Nurse Clinicians at the University of South Florida, Fall Term 1994, Pharmacology Department. “Simultaneous assessment of selegiline pharmacokinetics and metabolism from a 90-day toxicokinetic study in dogs”. Presented at Mid-Atlantic Population Approach Methods Users Group Meeting, Collegeville, PA, September 13, 1994 “Pharmacodynamics” Presented at Pharmaceutical Manufacturers Association Education and Research Institute’s Pharmacokinetics Course, Whipanny, NJ, September 18-20, 1994. “Pharmacodynamics”. Presented at Pharmaceutical Manufacturers Association Education and Research Institute’s Pharmacokinetics Course, Arlington, VA, September 17-20, 1995. “Nonlinear mixed effect modeling for population analysis with case studies using NONMEM”, Advanced Pharmacokinetics Graduate Course for Pharmaceutics Department at the University of Florida, April 9, 1996. “Pharmacodynamics”, “Advanced Topics in Bioequivalence”, and “Toxicokinetics and Preclinical ADME.” Presented at Pharmaceutical Manufacturers Association Education and Research Institute’s Pharmacokinetics Course, Merck Corporate Center, Somerset, NJ, May 20-23, 1996. “Pharmacodynamics”, “Advanced Topics in Bioequivalence”, and “Toxicokinetics and Preclinical ADME.” Presented at Pharmaceutical Manufacturers Association Education and Research Institute’s Pharmacokinetics Course, Merck Corporate Center, Somerset, NJ, November 17-20, 1996. "Replicate Crossover Designs for the Assessment of Individual Bioequivalence". Graduate Seminar Series, Pharmaceutics Department, College of Pharmacy, University of Florida, April 10, 1997. J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

INVITED PRESENTATIONS (cont.)
12.
“Individual Bioequivalence: Distribution of the Upper Limit, and the Effect of Scaling and Weighting Factors on Proposed Criteria”. 1997 MUFPADA Meeting, Ann Arbor, MI, May 1, 1997. “Industrial Perspective on Individual and Population Bioequivalence”. AAPS National Meeting, Boston, MA, November 5, 1997. “Pharmacodynamics”, “Advanced Topics in Bioequivalence”, and “Toxicokinetics and Preclinical ADME”. Presented at Pharmaceutical Manufacturers Association Education and Research Institute’s Pharmacokinetics Course, Georgetown University Medical Center, Washington, DC, October 19-22, 1997. “Review of Proposed FDA Bioequivalence Guidance”. Presented to PhRMA Ad Hoc Committee on Individual and Population Bioequivalence, PhRMA Headquarters, Washington, D.C., January 9, 1998. “Nonlinear Mixed-Effect Modeling”, Advanced Pharmacokinetic Graduate Course, Pharmaceutics Department, University of Florida, April 13-14, 1998. “Pharmacokinetics and Pharmacodynamics in Discovery and Early Development Phases”, AAPS Eastern Regional Meeting, Parsippany, N.J., June 1-2, 1998. “The Tyramine Challenge - A Pharmacodynamic Assessment of the Potential for Hypertensive Crisis: Case Studies with Selegiline Hydrochloride”, 1998 Spring Drug Metabolism, Clinical Pharmacology & Clinical Trial Workshop, Bethesda, MD, June 11-12, 1998. “PK/PD in Discovery and Early Development Phases”, Barnett-Parexel Workshop on Accelerating Pharmacokinetic/Pharmacodynamic Drug Development, Arlington, VA, March 25-26, 1999. “Development and Validation of a Population Pharmacokinetic Model for Efavirenz from Pooled Phase I Studies: Problems, Pitfalls, and Relevance to Patient Pharmacokinetics”, 7th Frontiers in Pharmacokinetics and Pharmacodynamics Meeting, Baltimore, MD, April 19-21, 1999. “Advancing PK/PD from Discovery Through Phase I”, Institute for International Research Workshop on Faster Phase I Clinical Trials: Strategies for Accelerating and Streamlining Drug Development, Washington, D.C., May 24-26, 1999. “A Practical, Balanced, Approach to Individual, Population, and Average Bioequivalence”, Pre-conference workshop for “Establishing Bioequivalence: Speeding Development & Meeting Regulatory Requirements” Meeting by the Institute for International Research, Philadelphia, PA, June 17-18, 1999. “Perspectives: PhRMA,” at the AAPS International Workshop on “Individual Bioequivalence: Realities and Implementation,” Montreal, Quebec, Canada, August 30 – September 1, 1999. J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

INVITED PRESENTATIONS (cont.)

24.
“Pharmacodynamics” and “Advanced Topics in Bioequivalence”. Presented at Pharmaceutical Manufacturers Association Education and Research Institute’s Pharmacokinetics Course, Baltimore, Maryland, October 18-20, 1999. “Advancing PK/PD from Discovery Through Phase I”, Institute for International Research Workshop on Faster Phase I Clinical Trials: Accelerating Proof-of-Concept to Speed Drug Development and Cut Costs, Miami Beach, FL, January 19-21, 2000. “Plasma Protein Binding of Anti-viral Agents and HIV Therapy: Theory and Practice,” Workshop on Pharmacokinetic and Pharmacodynamics of Protein Binding of Antibiotics 8th Annual BIOCON Meeting, Munich, Germany, March 12-15, 2000. “Determining Bioequivalence of Biologic Products via Biomarker Assessment,” Second Annual Establishing Bioequivalence: Speeding Development & Meeting Regulatory Requirements, Institute for International Research, Tampa, FL., May 18-20, 2000. “Need for Steady State Studies for ER Products,” AAPS Workshop on Biopharmaceutics in the New Millennium: Regulatory Approaches to Bioavailability and Bioequivalence, Washington, DC, September 11-13, 2000. “Determining Bioequivalence of Biologic Products via Biomarker Assessment,” Bioavailability and Bioequivalence: Examining 21 CFR 320 and Innovative Models, Techniques and Analysis, Barnett International, Washington, DC, February 27-28, 2001. “Surrogate Marker Development in an Industrial Setting,” University of Florida Gatorfest 2001, Dresden, Germany, June 16-17, 2001. “Dosing LMWH in Special Populations”, Biomed Research Foundation Workshop on Thrombosis, from Bench to Bedside, FDA, Washington, DC, November 27, 2001 “Plasma Protein Binding of Anti-viral Agents and HIV Therapy: Theory and Practice,” AAPS/Delaware Valley DMDG Symposium on Protein Binding, Bucks County Sheraton, November 28, 2001. “Appropriate Use of Biomarkers in Drug Development”, “Population Pharmacokinetics/Pharmacodynamics” and Clinical Trial Simulation” at Clinical Pharmacokinetics and Pharmacodynamics: Building the foundation for optimal predictions of drug design, action and dose, Institute for International Research, Philadelphia, PA, March 11-12, 2002. “Clinical Trial Simulation in an Industrial Setting” Institute for International Research, Washington, DC, August 23-24, 2002. “Population Pharmacokinetics” Two lectures as part of the University of Michigan Advanced Pharmacokinetics Course (Pharmaceutics Department, College of Pharmacy), Ann Arbor, Michigan, December 6, 2002 “Guiding Pediatric Dose Selection for the LMWH Tinzaparin via Bayesian Forecasting” Thomas Jefferson University Clinical Pharmacology Seminar, November, 2003 J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

“PK/PD Modeling” Thomas Jefferson University, Course Lecture for Principles of Clinical Pharmacology Course (PR 525), March 10, 2004 “Quantitative Approaches for Dose Adjustment for Specific Populations I: Case Study with LMWH” Applying Exposure-Response Concepts in Drug Development and Regulatory Review Course, Center for Drug Evaluation and Research, Food and Drug Administration, Washington, DC, April 29, 2004 “Medical Informatics Approaches to Improve Pediatric Dosing Guidance: Creation of a Pediatric Pharmacokinetic Knowledgebase” Pediatric Engineering Colloquia, Drexel University, Biomedical Engineering Department, April 30, 2004. “Statistical Issues With the Use of Safety and Efficacy Biomarkers in Drug Development” AAPS Workshop on Clinical Biomarkers in Drug Development: Efficacy Assessment, Pharmacokinetics / Pharmacodynamics and Regulatory Insights, Baltimore, Maryland, November 5, 2004 “PK/PD Modeling” Thomas Jefferson University, Course Lecture for Principles of Clinical Pharmacology Course (PR 525), February 9, 2005 “Evolving Data Signatures for Compounds Used in Pediatric Pharmacotherapy: M&S Approach to Translational Research”at Johnson and Johnson Pharmaceutical Research Institute Symposium, “Not Just Child’s Play: The Impact of Modeling & Simulation in Pediatric Drug Development,” Bridgewater Commons, Bridgewater, NJ, October 17, 2005 “Clinical Trials and Drug Research” at University of Pennsylvania Biotechnology (Penn Biotech) Seminar Series, Wharton Business School, Philadelphia, Pennsylvania, October 19, 2005 “Actinomycin-D and Vincrsitine Exposure-response Relationship: COG Effort” at Pediatric Oncology Subcommittee Meeting, US Food and Drug Administration, Rockville, MD, October 20, 2005 “PK/PD Modeling” Thomas Jefferson University, Course Lecture for Principles of Clinical Pharmacology Course (PR 525), February 11, 2006 “The In Silico Child” at joint meeting of the American College of Clinical Pharmacology (ACCP) and the (AGAH), Dusseldorf, Germany, February, 2006 “Modeling and Simulation Approaches for Compound Progression of Antiretroviral Agents” at HIV Preclinical – Clinical Therapeutics Research Meeting, May 15-16, 2006, Bethesda, MD (sponsored by NIMH and NIAID) “Modeling and Simulation Approaches for Compound Progression of Antiretroviral Agents” at New England Drug Metabolism Discussion Group, Annual Spring Symposium, June 9, 2006 J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia


INVITED PRESENTATIONS (cont.)

49.
“Pediatric Knowledgebase: A Hospital-based, informatics Approach to Improve Pediatric Patient Therapeutics” at The Children’s Hospital of Philadelphia’s Pharmacologic Basis of Pediatric Therapeutics Research Affinity Group Summer Symposium, “Clinical Pharmacologic Intervention into Pediatric Clinical Research: Informative Designs, Approaches and Informatic Integration, ”July 19, 2006 “Quantitative Pharmacology in a Translational Research Environment” at the AAPS/ACCP Joint Symposium: Quantitative X-ology: An Overarching Theme in Critical Path Drug Development, AAPS Annual Meeting 2006, San Antonio, TX, October 31, 2006 “Evolving Relevant Data Signatures for Compounds Utilized in Pediatric Pharmacotherapy: M&S Approach to Translational Research,” Clinical and Formulation Considerations in Designing Pediatric PK/PD Studies at the AAPS Annual Meeting 2006, San Antonio, TX, October 31, 2006 “Design and Implementation of a Paediatric Knowledgebase: A Decision Support Interface to Guide Patient Pharmacotherapy,” PKUK 2006 Meeting, Sheffield, England, November 17, 2006 “Modeling Concepts and Application - Individual and Population Approach with Case Studies Software and Algorithms: Walk-through analyses,” Oct 26, 2006 and “Model-based Application Topics: D-Optimality, LSM, Simulations including CTS,” Nov. 9, 2006, Temple University College of Pharmacy, Course # 509, Principles of Pharmacokinetics “Design and Implementation of a Pediatric Knowledgebase: A Decision Support Interface to Guide Patient Pharmacotherapy,” in the “Contemporary Therapeutic Drug Management: Integrating patient information, pharmacogenetic testing, PK model-based TDM and Informatics to Improve Clinical Care” session, March 23, 2007, ASCPT Annual Meeting, Anaheim, CA. “Optimizing Event-Driven Clinical Trial Efficiency with Discrete Event Simulation: Case Study with Pediatric Oncology Designs,” 19th ACCP Frontiers Symposium: “Innovative Approach for Early Drug Development – Disease Models and Novel Trial Design” Baltimore, MD, May 1, 2007 “Chicken Soup for the Clinical Pharmacologist: The Promise of Translational Medicine,” Annual ACCP Meeting, San Francisco, CA, September 9-12, 2007 “Integrating Modeling and Simulation Strategies into Targeted Translational Research,” International Symposium on Quantitative Pharmacology in Drug Development and Regulatory Sciences, Nanjing, China, Oct 28-31, 2007 (http://www.qpharmmeeting.com/). “Curriculum Development for the Next Generation Pharmacometrics Scientist,” International Symposium on Quantitative Pharmacology in Drug Development and Regulatory Sciences, Nanjing, China, Oct 28-31, 2007 J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

INVITED PRESENTATIONS (cont.)

59.
“Pharmacokinetics and Pharmacodynamics: A Gentle Introduction,” One Day Workshop for the Center for Clinical Epidemiology and Biostatistics (CCEB), University of Pennsylvania, December 14, 2007 “Simulation Techniques in Paediatric Drug Development,” HEXAL-Initiative Kinderarzneimittel Expert Workshop on The “in silico child” or Can we calculate children? Schloss Mickeln, Heinrich-Heine-Universität, Düsseldorf, Germany, February 14, 2008 (http://www.pharmazie.uni-duesseldorf.de/Institute/klin_pharm/Dokumente/Worksho14-15-Februar-2008.pdf). “Developing Drug Dashboards to Guide Paediatric Pharmacotherapy – Experience at the Children’s Hospital of Philadelphia,” HEXAL-Initiative Kinderarzneimittel Expert Workshop on The “in silico child” or Can we calculate children? Schloss Mickeln, Heinrich-Heine-Universität, Düsseldorf, Germany, February 15, 2008. “Impact of Modeling & Simulation on Advances in Translational Research,” American Conference on Pharmacometrics, Tuscon, Arizona, March 12, 2008 (http://mosaicnj.com/acop/schedule.php). “Evaluating Study Design and Conduct Efficiency of Event-Driven Clinical Trials via Discrete Event Simulation: Applications in Paediatric Oncology,” EMEA Workshop on Modelling in Paediatric Medicines, London, England, April 14, 2008 (http://www.emea.europa.eu/pdfs/conferenceflyers/Agenda_Workshop_on_Modelling_in%20Paediatric_Medicines.pdf). “Evaluating Study Design and Conduct Efficiency of Event-Driven Clinical Trials via Discrete Event Simulation: Applications in Pediatric Oncology,” Population Approach Group Japan (PAGJA) Meeting – Keynote Lecture, Daiichi Sankyo Pharmaceutical Company, Tokyo, Japan, June 20, 2008 (http://www.pagja.org/NEW/index.html). “Enhancing Methotrexate Pharmacotherapy in Children with Cancer: A Decision Support System Integrating Real-time PK/PD Modeling and Simulation with Patient Medical Records,” 25th Annual Meeting for the Japanese Society of Therapeutic Drug Monitoring (JSTDM) – Keynote lecture, Tokyo, Japan, June 21, 2008 (http://tdm2008.umin.jp/tdm2008_program.html) “Unresolved Challenges in Drug Development for Pediatrics,” 37th Annual ACCP Meeting Pre-meeting workshop on Prediction of Inter-individual Variability in ADME Using In Vitro Data Coupled with Modeling and Simulations: Focusing on Pediatric Pharmacokinetics, Philadelphia, Pennsylvania, September 13, 2008. J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PUBLICATIONS (Peer-reviewed Journals Only)
1.
Timko, R.J., Barrett, J.S., McHugh, P.A., Chen, S.T., and Rosenberg, H.A. Use of a motor
load analyzer to monitor the granulation process in a high intensity mixer. Drug Development
and Industrial Pharmacy
, 13 (3): 405-435, 1987.
Wahl, R.L., Barrett, J.S., Geatti, O., Wilson, B., Liebert, M., and Wagner, J.G. Intraperitoneal
delivery of radiolabeled monoclonal antibodies: studies on the regional delivery advantage.
Cancer Immunology and Immunotherapy, 26 (6): 187-201, 1988.
Barrett, J.S., Wahl, R.L., Wagner, J.G., Brown, R., and Fisher, S.J. Investigations into the
route of uptake and pharmacokinetics of intraperitoneally administered monoclonal antibodies:
I. Transdiaphragmatic blockade of the terminal lymphatics in the rat. Cancer Immunology and
Immunotherapy
, 31 (6): 365-372, 1990.
Barrett, J.S., Wahl, R.L., Wagner, J.G., and Fisher, S.J. Investigations into the route of uptake
and pharmacokinetics of intraperitoneally administered monoclonal antibodies: II. The effect of
protein dose and volume of IP injection in the rat. Journal of Cancer Research, 51 (13): 3434-
3444, 1991.
Mellott, M.J., Stabilito, I.I., Holahan, M.A., Cuca, G.C., Wang, S., Ping, L., Barrett, J.S.,
Lynch, J.J., and Gardell, S.F. Vampire bat salivary plasminogen activator promotes sustained
reperfusion in a canine model of arterial thrombosis. Arteriosclerosis and Thrombosis 12: 212-
221, 1992.
Vielhaber, J.P., Kuhlman, J.V., and Barrett, J.S. NONMEM version II implementation on a
VAX 9000: A DCL procedure for single-step execution and the unrealized advantage of a
vectorizing FORTRAN compiler. Computer Methods and Programs in Biomedicine, 40: 103-
115, 1993.
Peerlinck, K., DeLepeleire, I., Goldberg, M., Farrell, D., Barrett, J., Hand, E., Panebianco, D.,
Deckmyn, H., Vermylen, J., Arnout, J. MK-383 (L-700,462), a selective non-peptide platelet
glycoprotein IIb/IIIa antagonist, is active in man. Circulation 88[part 1]: 1512-1517, 1993.
Gertz, B.J., Barrett, J.S., Wittreich, J.M., Krupa, D.A., Siebold, J.R., Eisenhandler, R.M., and
Schneider, S.H. Growth hormone response in man to L-692,429, a novel nonpeptide mimic of
growth hormone releasing peptide (GHRP-6). J. Clin. Endocrin. Metab. 77(5): 1393-1397,
1993.
Barrett, J.S., Gould, R.J., Ellis, J.D., Holahan, M.M., Stranieri, M.T., Lynch, J.J., Hartman,
G.D., Ihle, N., Duggan, M., Moreno, O., and Theoharides, A.D. Pharmacokinetics and
pharmacodynamics of L-703,014, a potent fibrinogen receptor antagonist, after intravenous and
oral administration in the dog. Pharmaceutical Research 11(3): 426-431, 1994.
Vielhaber, J.P., Kuhlman, J.V., and Barrett, J.S. Updating NONMEM IV installation and
execution on the VAX 9000: A DCL procedure for single-step execution. Computer Methods
and Programs in Biomedicine
42: 71-72, 1994.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PUBLICATIONS (cont.)

11.
Vielhaber, J.P. and Barrett, J.S. NM-Win: A PC-based MS Windows front-end to NONMEM.
Pharmaceutical Research 11(5): 709-713, 1994.
Barrett, J.S., Murphy, M.G., Peerlink, K., De Lepeleire, I., Gould, R.J., Panebianco, D., Hand,
E., Deckmyn H., Vermylen, J., Arnout, J. Pharmacokinetics and Pharmacodynamics of MK-
383, a selective non-peptide platelet GP IIb/IIIa receptor anatgonist, in healthy men. Clin.
Pharmacol. Ther.
56: 377-388, 1994.
Barrett, J.S., Rohatagi, S., DeWitt, K.E., Morales, R.J., and DiSanto, A.R. The effect of dosing
regimen and food on the bioavailability of the extensively metabolized, highly variable drug,
Eldepryl (selegiline hydrochloride). Am. J. Ther. 3: 298-313, 1996.
Barrett, J.S, DiSanto, A.R., Thomford, P.J., Larsen, E.M., Palazzolo, M.J., and Morales, R.M.
Toxicokinetic Evaluation of a Selegiline Transdermal System (STS) in the Dog. Biopharm.
Drug Disposit.
18(2): 165-184, 1997.
Chen, S., Kumar, S., Barrett, J.S., and Wedlund, P. A genetic bias in clinical trials?:
Cytochrome P450-2D6 (CYP2D6) genotype in general vs selected healthy subject populations.
Br. J. Clin. Pharmacol. 44: 303-305, 1997.
Rohatagi, S., Barrett, J.S., DeWitt, K.E., and Morales, R.M. Pharmacokinetic evaluation of a
selegiline pulsatile oral delivery system. Biopharm. Drug Disposit. 18(9):665-680, 1997.
Rohatagi, S., Barrett, J.S., DeWitt, K.E., and Morales, R.M. Integrated pharmacokinetic
modeling of selegiline and metabolites after transdermal delivery. Biopharm. Drug Disposit.
18(7): 567-584, 1997.
Barrett, J.S., Hochadel, T.J., Morales, R.J., Rohatagi, S., DeWitt, K.E., Watson, S.K. and
DiSanto, A.R. Pharmacokinetics and safety of a selegiline transdermal system relative to single
dose oral administration in the elderly. Am. J. Ther. 3: 688-698, 1996.
Barrett, J.S., Szego, P., Rohatagi, S., Morales, R.M., DeWitt, K.E., Rajewski, G., and Ireland,
J. Absorption and presystemic metabolism of selegiline hydrochloride at different regions in the
gastrointestinal tract in healthy males. Pharmaceutical Research 13(10): 1533-1538, 1996.
Barrett, J.S., Wahl, R.L., and Fisher, S.J. Postural effects on peritoneal transport and systemic
uptake of radiolabeled monoclonal antibodies. Cancer Immunology and Immunotherapy, 44:
173-178, 1997.
Rohatagi, S., Barrett, J.S., Sawyers, W., Yu, K., and Morales, R.J. Pharmacokinetics of
ipriflavone and metabolites after oral administration of a corn oil suspension relative to the
Osteofix tablet. Am. J. Ther., 4: 229-238, 1997.
Rohatagi, S., Barrett, J.S., McDonald, L.J., Morris, E.M., Darnow, J., and DiSanto, A.R.
Selegiline percutaneous absorption in various species and metabolism by human skin.
Pharmaceutical Research 14(1): 50-55, 1997.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PUBLICATIONS (cont.)

23.
Rohatagi, S. and Barrett, J.S. Integrated pharmacokinetic modeling of ipriflavone and
metabolites after oral administration. Am. J. Ther. 4: 189-198, 1997.
Barrett, J.S., Hochadel, T.J., Morales, R.J., Rohatagi, S., DeWitt, K.E., Watson, S.K., Darnow,
J., Azzaro, A., and DiSanto, A.R. Tyramine pressor response following single 24-hr application
of a selegiline transdermal system (STS) in healthy males. J. Clin. Pharmacol. 37: 238-247,
1997.
Pieniaszek Jr, H.J., Mayersohn, M., Adams, M.P., Reinhart, R.J. and Barrett, J.S. Moricizine
bioavailability via simultaneous, dual isotope administration: bioequivalence implications. J.
Clin. Pharmacol
39: 817-825, 1999.
Barrett, J.S., Yu, J., Kapil, R., Padovani, P., Brown, F., Ebling, W.F., Corjay, M.H., Reilly,
T.M., Bozarth, J.M., Mousa, S.A. and Pieniaszek Jr, H.J. Disposition and exposure of the
fibrinogen receptor antagonist XV459 on α β
IIB 3 binding sites in the guinea pig. Biopharm. Drug Greenberg, H.E., Wissel, P., Barrett, J., Barchowsky, A., Gould R., Farrell, D., Panebianco, D.,
Hand, E., Gillen, L., Goldberg, M.R. and Bjornsson, T.D. Antiplatelet effects of MK-852, a
platelet fibrinogen receptor antagonist, in healthy volunteers. J. Clin. Pharmacol. 40: 496-507,
2000.
Barrett , J.S., Batra , V., Chow , A., Cook , J., Gould, A.L., Heller, A.H., Lo, M-W., Patterson,
S.D., Smith, B.P., Stritar , J.A., Vega, J.M., Zariffa, N. PhRMA Perspective on Population and
Individual Bioequivalence. J. Clin. Pharmacol., 40: 561-570, 2000.
Barrett , J.S., Batra , V., Chow , A., Cook , J., Gould, A.L., Heller, A.H., Lo, M-W., Patterson,
S.D., Smith, B.P., Stritar , J.A., Vega, J.M., Zariffa, N. Update on PhRMA Perspective on
Population and Individual Bioequivalence. J. Clin. Pharmacol., 40: 571-572, 2000.

30. Hochhaus G., Barrett J.S., and Derendorf H. An evolution of pharmacokinetics and
pharmacokinetic/dynamic correlations during the 20th century. J. Clin. Pharmacol., 40: 908-917, 2000. Barrett, J.S., Joshi, A.S., Chai, M., Ludden, T.M., Fiske, W.D. and Pieniaszek Jr., H.J.
Population Pharmacokinetic Meta-analysis with Efavirenz. Int. J. Clin. Pharmacol. Ther.
40(11): 507-519, 2002.
Barrett, J.S., Kornhauser, D.H., Hainer, J.W. Gaskill, J., Hua, T.A., Strogel, P., Johansen, K.,
van Lier, J.J., Knebel, W., Pieniaszek, H.J. Anticoagulant pharmacodynamics of tinzaparin
following 175 IU/kg subcutaneous administration to healthy volunteers. Thrombosis Res.101:
243-254, 2001.
Fossler, M.J., Barrett, J.S., Hainer, J.W., Riddle, J.G., Ostergaard, P., van der Elst, E., Sprogel,
P. Pharmacodynamics of intravenous and subcutaneous tinzaparin and heparin in healthy
volunteers. American J. Health-Syst Pharm.58: 1614-21, 2001.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PUBLICATIONS (cont.)

Barrett, J.S., Gibiansky , E., Hull, R.D., Planès, A., Pentikis, H. Hainer, J.W., Hua, T.A.,
Gastonguay , M. Population pharmacodynamics in patients receiving tinzaparin for the
prevention and treatment of deep vein thrombosis. Int. J. Clin. Pharmacol. Ther. 39(10): 431-
446, 2001.
Barrett, J.S. and Koprowski, S.P. The epiphany of data warehousing in the pharmaceutical
industry. Int. J. Clin. Pharmacol. Ther. 40 (Suppl 1): S3-S13, 2002.
Koprowski, S.P. and Barrett, J.S. Data Warehouse Implementation with Clinical
Pharmacokinetic/Pharmacodynamic Data. Int. J. Clin. Pharmacol. Ther. 40 (Suppl 1): S14-S29,
2002.
Hainer, J.W., Barrett, J.S., Assaid C., Fossler M., Cox, D., Leathers T., Leese P. Dosing in
heavy-weight/obese patients with the LMWH, tinzaparin: A pharmacodynamic study. Thromb.
Haemost
. 87: 817-23, 2002.
Hainer JW, Sherrard D, Swan SK, Pittenger A, Barrett JS, Fossler M, Cox D, Stephenson C,
Williams B, Assaid C, Hua A, Wilson S and Stoughton S. Intravenous and subcutaneous
weight-based dosing of the low molecular weight heparin, tinzaparin (Innohep), in end-stage
renal disease undergoing chronic hemodialysis. Am. J. Kidney Dis. 40(3): 531-8, 2002.
Fossler, MJ, Ebling WF, Ma S, Kornhauser D, Mondick J, Barrett JS, Garner D, Quon CY,
Pieniaszek Jr, HJ. Integrated pharmacokinetic/pharmacodynamic model of XV459, a potent and
specific GPIIb/IIIa inhibitor, in healthy male volunteers. J. Clin. Pharmacol 42(12): 1326-34,
2002.
Mousa, SA, Bozarth J, Johansen, K, and Barrett, JS. Tinzaparin molecular weight distributions
are potent stimulants for sustained release of plasma tissue factor pathway inhibitor in healthy
human subjects. J. Clin. Pharmacol. 43(7): 727-734, 2003.
Rohatagi S, Arya V, Zech K, Nave R, Hochhaus G, Jensen BK, Barrett, J.S. Population
pharmacokinetics and pharmacodynamics of ciclesonide. J. Clin. Pharmacol. 43(4): 365-378,
2003.
Martin NE, Read KA, Martin LL, Tardif S, Wray H, Barrett JS. Pharmacoscintigraphic
assessment of the regional drug absorption of a dual ACE/NEP inhibitor, M100,240 in healthy
volunteers. J. Clin. Pharmacol. 43(5): 529-538, 2003.
Martin NE, Howell S, Martin, LL, Cirillo I, Barrett, JS. No clinically relevant CYP 3A4
induction with the dual ACE/NEP inhibitor, M100,240. J. Clin. Pharmacol. 44(4): 379-387,
2004.
Pfister M, Martin NE, Haskell LP, Barrett JS. Optimizing dose selection with modeling and
simulation: application to the vasopeptidase inhibitor M100240. J. Clin Pharmacol 44(6): 621-
631, 2004.
Shi J, Montay G, Chapel S, Hardy P, Barrett JS, Sack M, Marbury T, Swan S, Vargas R,
Leclerc V, Leroy B and Bhargava V. Pharmacokinetics and safety of the ketolide telithromycin
in patients with renal impairment. J. Clin Pharmacol. 44(3): 234-244, 2004.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PUBLICATIONS (cont.)

Zuppa AF, Adamson PC, Barrett JS. Letter to the Editor, Pediatric drug labeling: improving
the safety and efficacy of pediatric therapies, J Pediatr. Pharmacol Ther 9(1): 70-71, 2004.
Cirillo I, Martin NE, Brennan B., Barrett, JS. The effect of food on the pharmacokinetics of a
dual ACE/NEP inhibitor, M100240. J Clin. Pharmacol. 44(12): 1379-84, 2004.
Barrett JS, Collison KR. Dosing LMWH in special populations: safety, PK/PD and monitoring
considerations. International J of Cardiovascular Med and Science 4(2): 41-54, 2004.
Shi J, Chapel S, Montay G, Hardy P, Barrett JS, Sica D, Swan S, Noveck R, Leroy B and
Bhargava V. Effect of ketoconazole on the pharmacokinetics and safety of telithromycin and
clarithromycin in older subjects with diminished renal function. Int. J. Clin Pharmacol. 43(3):
123-133, 2005
Shi J, Pfister M, Jenkins SG, Chapel S, Barrett JS, Port RE, Howard D. Pharmacodynamic
analysis of the microbiological efficacy of telithromycin in patients with community-acquired
pneumonia. Clinical Pharmacokinetics 44(3): 317-329, 2005.
Barrett JS, Labbe L, Pfister M. Application and impact of population pharmacokinetics in the
assessment of antiretroviral pharmacotherapy. Clinical Pharmacokinetics 44(6): 591-625, 2005.
Zuppa AF, Mondick J, Davis LA, Maka D, Tsang B, Narayan M, Nicholson C, Patel D, Collison KR, Adamson PC, Barrett JS. Drug Utilization in the Pediatric Intensive Care Unit: Monitoring Prescribing Trends and Establishing Prioritization of Pharmacotherapeutic Evaluation of Critically-ill Children. J. Clin. Pharmacol. 45: 1305-1312, 2005. Skolnik J, Barrett JS, Shi H, Adamson PC. A liquid chromatography-tandem mass
spectrometry method for the simultaneous quantification of actinomycin-D and vincristine in
children with cancer. Cancer Chemother Pharmacol. 57(4):458-64, 2006.
Meibohm B, Panetta C, Barrett JS. Population pharmacokinetic studies in pediatrics: Issues in
design and analysis. AAPS Journal. 7(2): Article 48: E475-E487, 2005.
Kenna LA, Labbe L, Barrett JS, Pfister M. Modeling and simulation of adherence: Approaches
and applications in Therapeutics. AAPS Journal. 7(2): E390-E407, 2005.
Zuppa AF, Nicolson SC, Adamson PC, Wernovsky G, Mondick JT, Burnham N, Hoffman TM,
Gaynor WJ, Davis LA, Greeley WJ, Spray TL, Barrett JS. Population Pharmacokinetics of
Milrinone in Neonates with Hypoplastic Left Heart Syndrome Undergoing Stage 1
Reconstruction, Anesthesia & Analgesia 102(4):1062-9, 2006.
Lee J, Wu D, Hsu BH, Barrett JS. Separation and Characterization of Silybin, Isosilybin,
Silydianin and Silychristin in Milk Thistle Extract by Liquid Chromatography-electrospray
Tandem Mass Spectrometry. J Chromatogr A 1116(1-2):57-68, 2006.
Lee JI, Narayan M and Barrett JS. Analysis and comparison of active constituents in
commercial standardized silymarin extracts by liquid chromatography–electrospray ionization
mass spectrometry. J Chromatogr B 845: 95-103, 2007.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PUBLICATIONS (cont.)
Barrett JS, Gupta M, Mondick JT. Model-based Drug Development for Oncology Agents.
Expert Opinion on Drug Discovery 2(2): 185-209, 2007.
Barrett JS. Facilitating Compound Progression of Antiretroviral Agents via Modeling and
Simulation. J Neuroimmune Pharmacol 2:58-71, 2007.
Lee JI, Skolnick JM, Barrett JS and Adamson PC. A sensitive and specific liquid
chromatography-tandem mass spectrometry method for the simultaneous quantification of
actinomycin-D and vincristine in children with cancer. J Mass Spectrom 42:761-770, 2007.
Zuppa AF, Vijayakumar S, Mondick JT, Pavlo P, Jayaraman B, Patel D, Narayan M, Boneva T,
Vijayakumar K, Adamson PC, Barrett JS. Design and implementation of a web-based hospital
drug utilization system. J Clin Pharmacol: 47(9): 1172-1180, 2007.
Barrett JS. Quantitative Pharmacology in a Translational Research Environment. Chinese J
Clin Pharmacol Therapeut
: 12(10): 1081-88, 2007.
Sorenmo K, Samluk M, Clifford C, Baez J, Barrett JS, Poppenga R, Overley B, Skorupski K,
Oberthaler K, Van Winkle T, Seiler G, Shofer F. Clinical and pharmacokinetic characteristics
of intracavitary administration of pegylated liposome encapsulated doxorubicin in dogs with
splenic hemangiosarcoma. J Vet Intern Med 21: 1347-1354, 2007
Mondick JT, Gibiansky L, Gastonguay MR, Skolnik J, Veal GJ, Boddy A, Adamson PC,
Barrett JS. Population Pharmacokinetics of Actinomycin-D in Children and Young Adults. J
Clin Pharmacol:
48: 35-42, 2008
Skolnik JT, Barrett JS, Jayaraman B, Patel D, Adamson PC. Shortening the Timeline of
Pediatric Phase 1 Trials: The Rolling Six Design. J. Clin Oncol 26(2): 190-5, 2008
Barrett JS, Mondick JT, Narayan M, Vijayakumar K, Vijayakumar S. Integration of Modeling
and Simulation into Hospital-based Decision Support Systems Guiding Pediatric
Pharmacotherapy. BMC Medical Informatics and Decision Making 8:6, 2008.
Barrett JS. Applying Quantitative Pharmacology in an Academic Translational Research
Environment. AAPS Journal 10(1):9-14, 2008.
Barrett JS, Jayaraman B, Patel D, Skolnik JM. A SAS-based solution to evaluate study design
efficiency of phase I pediatric oncology trials via discrete event simulation. Computer Methods
and Programs in Biomedicine
90: 240-250, 2008.
Thompson PA, Gupta M, Rosner GL, Yu A, Barrett JS, Bomgaars LM, Bernstein ML, Blaney
SM, Mondick JT. Pharmacokinetics of Irinotecan and its Metabolites in Pediatric Cancer
Patients: A report from the Children's Oncology Group. Cancer Chemotherapy and
Pharmacology
62: 1027-37, 2008.
Adamson PC and Barrett JS. All Dex’ed Out With Nowhere To Go? J. Clin Oncol 26(12):
1917-1918.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

PUBLICATIONS (cont.)

Robinson BW, Behling KC, Gupta M, Zhang AY, Moore JS, Bantly AD, Willman CL, Carroll
AJ, Adamson PC, Barrett JS, Felix CA: Abundant anti-apoptotic BCL-2 is a molecular
target in leukemias with t(4;11) translocation. Br J. Haematol 141(6):827-39, 2008.
Barrett JS, Fossler MJ, Cadieu, KD and Gastonguay MR. Pharmacometrics, A
Multidisciplinary Field to Facilitate Critical Thinking in Drug Development and Translational
Research Settings. J Clin. Pharmacol 48(5): 632-49, 2008
Zuppa AF, Barrett JS. Pharmacokinetics and pharmacodynamics in the critically ill child.
Pediatr Clin North Am. 55(3):735-55, 2008.
Mondick JT, Oo C, Patel D, Fujitani T, Shimizu K, Zimmerman T, Barrett JS. Population
Pharmacokinetics of the Selective Serotonin Receptor Partial Agonist Piclozotan in Healthy
Subjects and Stroke Patients. (accepted, Am J Therapeutics)
Menon-Andersen D, Mondick JT, Jayaraman B, Thompson PA, Blaney SM, Adamson PC,
Barrett JS. Population Pharmacokinetics of Imatinb Mesylate and its Metabolite in Children
and Young Adults. (accepted, Cancer Chemother and Pharmacol)
Skolnik JM and Barrett JS. Refining the Phase 1 Pediatric Trial. Pediatric Health 2(2): 105-
106, 2008.
Gross R, Aplenc R, TenHave T, Foulkes AS, Thakur R, Mosepele M, Barrett JS, Flexner C,
Strom BL, Bisson G. Slow Efavirenz Metabolism Genotype is Common in Botswana (accepted,
JAIDS).
Barrett JS, Shi J, Xie H, Huang X, Fossler MJ and Sun R. Globalization of Quantitative
Pharmacology: First International Symposium of Quantitative Pharmacology in Drug
Development and Regulation. J Clin Pharmacol 48(7): 787-792, 2008.
Barrett JS, Patel D, Jayaraman B, Narayan M, Zuppa A. Key Performance Indicators for the
Assessment of Pediatric Pharmacotherapeutic Guidance. J Pediatr Pharmacol Ther 13:141-155,
2008.
Wade KC, Wu D, Kaufman DA, Ward RM, Benjamin DK, Ramey N, Jayaraman B, Kalle H,
Adamson PC, Gastonguay M, Barrett JS. Population Pharmacokinetics of Fluconazole in
Young Infants (accepted, Antimicrob Agents Chemother.).
Barrett JS, Skolnik JM, Jayaraman B, Patel D, Adamson PC. Improving Study Design and
Conduct Efficiency of Event-Driven Clinical Trials via Discrete Event Simulation: Application
to Pediatric Oncology (accepted, Clinical Pharmacol Ther)
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

MANUSCRIPTS IN PREPARATION / SUBMITTED

1. Rowan C, Brinker AD, Nourjah, P, Chang J, Mosholder A, Barrett JS, Avigan M.
Rhabdomyolysis reports show interaction between simvastatin and CYP3A4 inhibitors, (submitted, Pharmacoepidemiology and Drug Safety).
2. Wu D, Paul DJ, Zhao X, Douglas SD, Barrett JS. A sensitive and rapid liquid
chromatography-tandem mass spectrometry method for the quantification of the novel neurokinin-1R antagonist aprepitant in rhesus macaque plasma, and cerebral spinal fluid, and human plasma with application in translational NeuroAIDs research. (submitted, J Pharm Biomed Anal). 3. Wade KC, Benjamin Jr. DK, Kaufman DA, Ward RM, Smith PB, Jayaraman B, Adamson PC, Gastonguay M, Barrett JS. Fluconazole dosing for the prevention or treatment of invasive
candidiasis in young infants (submitted, Ped Infectious Disease J)
4. Zhang AY, Rege, J, Robinson BW, Gupta M, Barrett JS, Adamson PC, Celenza-Behling K,
Bantly A, Moore J, Felix CA. Pan-BCL-2 family small molecule inhibitor GX015-070 (GeminX, Inc.) exhibits single agent cytotoxicity, is synergistic with select anti-leukemia cytotoxic agents, and induces apoptosis in cell lines with t(4:11)(q21;q23) translocations (in preparation) 5. Gupta M, Wade K and Barrett JS. Optimizing Fluconazole Dosing in Preterm Neonates
Based on Simulations from Posterior Parameter (Uncertainty) Distributions (in preparation) 6. Narayan M, Patel D, Marx A, Adamson PC, Barrett JS. Pediatric dosing guidance trends and
attitudes among the prescriber community (in preparation). 7. Barrett JS, Vijayakumar S, Mondick JT, Vijayakumar K, Zuppa A, Jayaraman B, Cummins E, Narayan M, Adamson PC, Norris R, Skolnik JM. Improving Methotrexate Pharmacotherapy in Children with Cancer: Decision Support Integrating Real-time PK/PD Modeling and Simulation with Patient Medical Records (in preparation). 8. Cummings E, Jayaraman B, Mondick JT, Norris R, Narayan M, Barrett JS. Evaluating performance and validation of a decision support system design to improve methotrexate drug management in children with cancer. 9. Barrett JS, Adamson PC, Narayan M, Zuppa A, Skolnik JM, Mondick JT, Marsenic O, Menon D, Wade K, Jayaraman B, Patel D, Vijayakumar K,Vijayakumar S. A Pediatric Knowledgebase to Guide Pharmacotherapy: Patient-specific Dosing Guidance for All Children. 10. Galinkin JL, Aplenc R, Rebbeck T, Shi H, Adamson PC and Barrett JS. Midazolam as a Pharmacologic Probe for CYP 3A4/3A5 Phenotyping. 11. Barrett JS, Narayan M, Patel D, Collison K. De facto dosing guidance in children: Is there a 12. Barrett JS, Mitchell LG, Patel D, Cox P, Vegh P, Castillo M, Massicotte P. A Population- based Analysis of Dalteparin Pharmacokinetics in Pediatric Patients at Risk for Thromboembolic Events. J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

BOOK CHAPTERS
Barrett, JS.
Population Pharmacokinetics in “Pharmacokinetics in Drug Discovery and
Development.” pp 315-356. Schoenwald R. editor, CRC Press Inc, 2002 (ISBN: 1-5667-6973-6).
Gastonguay M, Gibiansky E, and Barrett JS. Optimizing a bayesian dose-adjustment scheme for a
pediatric trial: a simulation study in “Simulation for Designing Clinical Trials.” pp. 369-390. Kimko,
H. and Duffel S. editors, Drugs and the Pharmaceutical Sciences Vol. 127, Marcel Dekker Inc., New
York, 2002 (ISBN: 0-8247-0862-8).
Rohatagi S, Martin N and Barrett JS. Pharmacokinetic/Pharmacodynamic Modeling in Drug
Development in “Applications of Pharmacokinetic Principles in Drug Development” Krishna R.
editor, Kluwer Academic/Plenum Publishers, Hingham, MA, 2003 (ISBN: 0-306-4766-1).
Barrett, JS and Collison, KR. Dosing LMWHs in Special Populations, in “Thrombosis Research and
Treatment: Bench to Bedside.” Vossoughi J, Fareed J, Mousa SA, and Karanian JW. editors, Medical
and Engineering Publishers, Inc., Washington, DC, 2004 (ISBN: 1-930636-03-2).
Barrett, JS. Bioavailability and Bioequivalence Studies in “Pharmacokinetics in Drug Development:
Clinical Study Design and Analysis, Volume 1,” Bonate, PL and Howard, DR. editors, AAPS Press,
Arlington, VA, 2004 (ISBN: 09711767-4-4 (v.1)).
Barrett, JS. Bioequivalence of Biologics in “Pharmacokinetics and Pharmacodynamics of Biotech
Drugs.” Bernd Meibohm Editor, Wiley-VCH Verlag GmbH & Co KGaA, Weinheim, 2006 (ISBN: 3-
527-31408-3).
Zuppa, AF and Barrett, JS. Pharmacology in “Rogers Textbook of Pediatric Intensive Care, 4th
Edition” David Nichols Editor, Lippincott William & Wilkins, Philadelphia, PA, 2008 (ISBN-13: 978-
0-7817-8275-3)
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS

1.
Barrett, J.S., Timko, R.J., and Chen, S.T. Granulation process characterization in a high shear
mixer using a motor load analyzer. 39th Annual APhA Meeting, October 20-24, 1985.
Yeh, K.C., Winchell, G.A., and Barrett, J.S. A program for calculating AUC in
pharmacokinetics using stable piecewise polynomial interpolants. JUC Pharm. Sci., December
2-5, 1987.
Barrett, J.S., Geatti, O., Wilson, B., Liebert, M., Wagner, J.G., and Wahl, R.L. An
examination of antibody class fragments with respect to absorption from the peritoneal cavity in
normal and tumor-involved mice and rats. J. Nuc. Med. 29(5, suppl.): 900, 1988.
Barrett, J.S., Wahl, R.L., Wagner, J.G., and Fisher, S.J. Effect of injection volume and protein
dose on the pharmacokinetics of intraperitoneally administered monoclonal antibodies. J. Nuc.
Med.
29 (5, suppl.): 889, 1988.
Barrett, J.S., Wagner, J.G., Fisher, S.F., and Wahl, R.L. Enhanced regional delivery of
monoclonal antibodies to the peritoneal cavity by transdiaphragmatic blockade. J. Nuc. Med. 30
(5, suppl.): 815, 1989.
Wahl, R.L., Barrett, J. and Fisher S. Anti-mouse antibody effects on biodistribution of intact
and Fab fragments of monoclonal antibodies: animal studies. J. Nuc. Med. 30(5, suppl.): 847,
1989.
Clavo, A.C., Barrett, J.S., Jackson, G.A., and Wahl, R.L. Immuno-fluorescent screening of
monoclonal antibodies to surface antigens on human tumor cells. 1990 Pandex Users
Symposium, May 3-5, 1990.
Barrett, J.S., Wahl, R.L., Wagner, J.G., and Fisher, S.J. Optimization of intraperitoneal
antibody delivery: additional studies of protein dose and volume effects. J. Nuc. Med. 31(5,
suppl.): 850, 1990.
Mellott, M.J., Stabilito, I.I., Barrett, J.S., Lynch, J.J., and Gardell, S.F. Vampire bat salivary
plasminogen activator promotes sustained reperfusion in a canine model of arterial thrombosis.
Circulation 84(4, suppl II): II-465, 1991.
Barrett, J.S., Gould, R.J., Dorley, J.M., Holahan, M.A., Stranieri, M.T., and Theoharides, A.D.
Pharmacokinetics and pharmacodynamics of L-703,014, a potent fibrinogen receptor antagonist,
after intravenous and oral administration in the dog. Pharmaceutical Research 9(10): S358,
1992.
Wissel, P.S., Barrett, J.S., Bjornsson, T.D., Barachowsky, A., Gould, R.J., Hand, E., Farrell,
D., and Panebianco, D. Pharmacokinetics and pharmacodynamic effects of MK-852, a platelet
fibrinogen receptor antagonist. Pharmaceutical Research 9(10): S293, 1992.
Barrett, J.S., Fisher, S.J., and Wahl, R.L. Optimizing intraperitoneal radioimmunotherapy:
postural effects on peritoneal transport and systemic uptake of radiolabeled monoclonal
antibodies. J. Nuc. Med. 33(5, suppl.): 959, 1992.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS (cont.)

13.
Gould, R.J., Barrett, J.S., Ellis, J.D., Holahan, M.A., Stranieri, M.T., Theoharides, A.D.,
Lynch, J.J., Friedman, P.A., Duggan, M.E., Ihle, N.C., Anderson, P.S. and Hartman, G.D.
Characterization of L-703,014, a novel fibrinogen receptor antagonist, following oral
administration to dogs. Thrombosis and Heamostasis 69(6): 539, 1993.
Sutton, J., Topol, E., Rossen, J.D., Runge, M., Ghannam, A., Fitzpatrick, V., Hand, E., Barrett,
J.S.
, and Sax, F.L. Inhibition of platelet aggregation with an infusion of MK-383 in stable
coronary artery disease. Clinical Research 41(2): 118A, 1993.
Vielhaber, J.P. and Barrett, J.S. A PC-based front end to NONMEM (Version 4) running
under MS Windows (Version 3.1). Pharmaceutical Research 10(10): S-399, 1993.
Barrett, J.S., Ghannam, A., Hand, E., and Sax, F.L. Designing consecutive infusion regimens
for IV fibrinogen receptor antagonist phase IIa studies in CAD patients based on phase-I PK/PD.
Pharmaceutical Research 10(10): S-368, 1993.
Hatangadi, S., Grasing, K., Murphy, M.G., Seibold, J.R., Barrett, J.S., Chavez, C., Constanzer,
M., Vigna, T., Baglivo, P., Capra, N., Gonyo, G. and Knuppel, R.A. Human tolerability and
pharmacokinetics of L-368,899: a novel oxytocin receptor antagonist. Presented at Society for
Gynecologic Investigation Meeting, Chicago, Illinois, 3/22/94 - 3/25/94.
Michael, M.M. and Barrett, J.S. SAS/PH-Kinetics software for non-compartmental
pharmacokinetic analysis and data management. Pharmaceutical Research 11(10): S360, 1994.
Barrett, J.S., Rohatagi, S., DeWitt, K.E., and Morales R.M. Bioequivalence of selegiline HCl:
Guidance for a “highly variable” drug. Clin. Pharmacol. Ther. 59(2): PIII-75, 206, 1996.
Rohatagi, S., Barrett, J.S., DeWitt, K.E., and Morales, R.M. Pharmacokinetics and releative
bioavailability of orally-administered ipriflavone tablets, corn oil emulsion, and aqueous
suspension in healthy males. Pharmaceutical Research 13(9): S459, 1996.
Rohatagi, S., Barrett, J.S., DeWitt, K.E., and Morales, R.M. Integrated pharmacokinetic/
metabolic modeling of selegiline after transdermal administration. Pharmaceutical Research
13(9): S418, 1996.
Rohatagi, S., Barrett, J.S. Integrated pharmacokinetic/ metabolic modeling of ipriflavone and
metabolites after oral administration. Pharmaceutical Research 13(9): S500, 1996.
Rohatagi, S., Barrett, J.S., McDonald L.J., Morris, E.M., and Darnow, J. In vitro percutaneous
absorption in various species and metabolism by human skin of selegiline and its in vivo
implications. Pharmaceutical Research 13(9): S417, 1996.
Rohatagi, S., Barrett, J.S., DeWitt, K.E., and Morales, R.M. Multiple dose pharmacokinetics
and dose proportionality of selegiline and metabolites in healthy males following transdermal
administration. Pharmaceutical Research 13(9): S502, 1996.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS (cont.)
25.
Barrett, J.S., Rohatagi, S., Szego, P., Morales, R.J., Rajewski, G., and Ireland J. Site-specific
GIT absorption/metabolism of selegiline HCl in healthy males. Pharmaceutical Research
13(9): S412, 1996.
Barrett, J.S., Hochadel, T., Rohatagi, S., DeWitt, K.E., Watson, S., and DiSanto, A.R.
Tyramine pressor response following single 24-hour application of a selegiline transdermal
system (STS) in healthy males. Pharmaceutical Research 13(9): S122, 1996.
Barrett, J.S., Rohatagi, S., Morales, R.M., and DiSanto, A.R. Effect of analytical sensitivity on
bioequivalence metrics exhibiting truncated distributions at assay LLOQ: A case study with
selegiline HCL. Pharmaceutical Research 13(9): S477, 1996.
Azzaro, A.J., Barrett, J.S., Blume, C.D., Bobotas, G., DiSanto, A.R., and Hochadel, T.J. New
insights into selegiline metabolism and advantages of a transdermal formulation. Presented at
ANCP Meeting, Puerto Rico, December 13-15, 1996.
Barrett, J.S., Joshi, A.S., Chai M-F, Fiske, W.D., and Ludden, T.M. Model building and
validation of a population pharmacokinetic model for efavirenz. PharmSci 1(1) Suppl., S, 1998.
Chai, M., Joshi, A.S. and Barrett, J.S. A database system for rapid data subsetting and
extraction of population-based data for eventual NONMEM implementation. PharmSci 1(1)
Suppl., S517, 1998.
Joshi, A.S., Barrett, J.S., Chai, M.F., Fiske, W.D., and Ludden, T.M. Population
pharmacokinetics of efavirenz in adult HIV-infected patients. PharmSci 1(1) Suppl., S135,
1998.
Joshi, A.S., Barrett, J.S., Fiske, W.D., Bacheler, L.L., Pieniaszek, H.J., Ludden, T.L.
Population pharmacokinetics of efavirenz in phase II studies and relationship with efficacy.
(Presented at 39th ICAAC Meeting).
Barrett, J.S., Yu, J., Kapil, R., Padovani, P., Brown, F., Ebling, W.F., Corjay, M.H., Reilly,
T.M., Bozarth, J.M., Mousa, S.A., and Pieniaszek Jr., H.J., Disposition and exposure of
GPIIb/IIIa antagonist, XV459, on α β
IIB 3 binding sites in the guinea pig. (Presented at Annual Gibiansky, E., Pentikis, H.S., and Barrett, J.S. Population pharmacokinetic analysis of anti-Xa
activity of tinzaparin from phase III clinical trials. AAPS PharmSci 1(4), Suppl., S83, 1999.
Lee, B., Ng, A., Paulussen, R.J.A., Chen, K., and Barrett, J.S. Improved chromogenic assay
for quantification of anti-Xa activity in citrated human plasma. AAPS PharmSci 1(4), Suppl.,
S530, 1999.
Benedek IH, Barrett J.S., Fiske, W.D., Stevenson D.L., Joseph J.L., and Kornhauser D.M.
Evaluation of the effect of efavirenz on the pharmacokinetics of lorazepam in healthy
volunteers. Presented at the 37th Annual Meeting of Infectious Diseases Society of America,
Philadelphia, PA, November 18-21, 1999.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS (cont.)

37.
Koprowski, S.P., Barrett, J.S., Bara, T.W., and Fowler, D. Constructing a Data Warehouse for
Pharmacokinetic Data. (Presented at Annual SAS Users Group International Meeting,
Indianapolis, IA, 2000).
Gastonguay, M.R., L. Gibiansky, L., Gibiansky, E., and Barrett, J.S. Optimizing a bayesian
dose-adjustment scheme for a pediatric trial: A simulation study. Clin. Pharmacol. Ther. 67(2):
138, 2000
Barrett, J.S., Fiske, W.D. and Joshi, A.S. Plasma protein binding of anti-viral agents and HIV
therapy: Theory and practice. Antiinfect. Drugs Chemother. 17(1): 58, 2000.
Barrett, J.S., Kornhauser, D.H., Hainer, J.W. Gaskill, J., Hua, T.A, Strogel, P., Pieniaszek, H.J.,
Johansen, K., van Lier J.J., Knebel W. Anticoagulant pharmacodynamics of tinzaparin
following 175 IU/kg subcutaneous administration to healthy volunteers, International J. of
Hematology 72 (Suppl 1): 147, 2000.
Fossler, M.J., Ebling, W.F., Kornhauser, D., Ma, S., Mondick, J., Charnick, S.B., Barrett, J.S.,
Garner, D., Koprowski, S.P., Quon, C.Y. and Pieniaszek, H.J. Pharmacokinetics and
Pharmacodynamics of Roxifiban (DMP 754) in healthy male volunteers. J. Clinical
Pharmacology 40(9): 1059, 2000.
Mousa, S.A., Bozarth, J., Hainer, J.W., Sprogel, P., Johansen, K., Barrett, J.S.
Pharmacodynamic effects of tinzaparin following 175 IU/kg subcutaneous administration in
healthy volunteers on plasma tissue factor pathway inhibitor (TFPI). Thrombosis and
Heamostasis 2001(July):86 (Supplement): P2299.
Barrett J.S., Mitchell D.J., Gastonguay M., Mitchell L., Shockcor J., Andrew M. Forecasting
anti-Xa activity in a pediatric dose finding trial with tinzaparin. Thrombosis and Heamostasis
2001(July):86 (Supplement): P2307.
Mitchell D.J., Barrett J.S., Vegh P., Mitchell L., Chan A., Lee B., Andrew M. Ensuring
analytical quality control in anti-Xa monitoring: application to a dose-finding pharmacodynamic
trial with tinzaparin in paediatric patients. Thrombosis and Heamostasis 2001(July):86
(Supplement).
Andrew M., Marzinotto V., Mitchell D.J., Barrett J.S., Hainer J.W. Design aspects of dose-
finding trials in pediatric patients with severe TE: Tinzaparin pediatric study. Thrombosis and
Heamostasis 2001(July):86 (Supplement).
Barrett J.S., Hainer J.W., Leese P.T., Leathers T.W., Assaid C.A., Walsh M.L., Read K.A.,
Wilson S.E. Pharmacodynamics (PD) of the low molecular weight heparin, tinzaparin, in obese
volunteers. Thrombosis and Heamostasis 2001(July):86 (Supplement): P2305.
Hainer J.W., Barrett J.S., Swan S., Sherrard D., Williams R.M., Fossler M.J., Mondick J.T.,
Walsh M.L., Stevenson C., Wilson S.E. Pharmacodynamics (PD) of the LMWH, tinzaparin, in
renal failure patients following IV and SC administration. Thrombosis and Heamostasis
2001(July):86 (Supplement): P2304.
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS (cont.)

48.
Rohatagi S., Arya V., Zech K, Barrett J.S., Hochhaus G., Jensen BK. Population
pharmacokinetics/pharmacodynamics of ciclesonide. J. Allergy and Clinical Immunology
109(1): S236 (# 716), 2002.
Nancy E. Martin, Kathryn A. Read, Louis Martin, Sarah Tardif, Heather Wray, and Jeff
Barrett.
Pharmacoscintigraphic Assessment of the Regional Drug Absorption of M100240 in
Healthy Volunteers. Accepted for poster and podium presentation at ACCP October 21-23,
2002.
Martin NE, Howell S, Cirillo I, Martin L, King P, Barrett J. No Clinically Relevant CYP3A4
Induction with M100240 and MDL100,173, A Dual ACE/NEP Inhibitor. Accepted for
presentation at AAPS November 10-13, 2002.
Shi J, Montay G, Chapel S, Hardy P, Barrett J, Sack M, Marbury T, Swan S, Vargas R, Leclerc
V, Leroy B, Bhargava V. Pharmacokinetics and safety of telithromycin after single and multiple
doses in patients with renal impairment. Clin. Pharmacol. Ther. 2003; 73(2): P35 (PII-21).
Shi J, Chapel S, Montay G, Hardy P, Barrett J, Sica D, Swan S, Noveck R, Leroy B, Bhargava
V. Effect of ketoconazole on the pharmacokinetics and safety of telithromycin and
clarithromycin in elderly subjects with diminished renal function. Clin. Pharmacol. Ther. 2003;
73(2): P35 (PII-22).
Chapel S, Barrett JS, and Pfister M. Modeling and simulation approach to discriminate true
food effects: Comparison with noncompartmental methods. PAGE 12 (2003) Abstr 452
[www.page-meeting.org/?abstract=452].
Krishnaswami S, Kittner B, Sankoh AJ, Barrett JS. Population pharmacokinetics of
fexofenadine in pediatric patients. J Clin Pharmacol 2003; 43: 1016 (Abstr. 2).
Zuppa AF, Adamson PC, Barrett JS, Maka D, Davis LA, Tsang B, Nadkarni V. Lack of
Pediatric Pharmacokinetic (PK) Data for Medications Used in Critically Ill Children. Crit Care
Med 2003; 31 (12): 492 Part 2 Suppl. S DEC 2003. (A10#38. Presented at the 33rd Society of
Critical Care Medicine Conference, February, 2004).
Barrett JS, Skolnik J, Gastonguay MR and Adamson PC. The Value of Priors and Prior
Uncertainty in Clinical Trial Simulation: Case Study with Actinomycin-D in Children with
Cancer. PAGE 13 (2004) Abstr 504 [www.page-meeting.org/?abstract=504].
Barrett JS, Zuppa A, Schreiner M and Adamson PC. Esmolol Population Pharmacokinetics in
Critically-ill, Pediatric Patients. PAGE 13 (2004) Abstr 490 [www.page-
meeting.org/?abstract=490].
Collison KR, Narayan M, Nicholson C, Patel D, Zuppa A, Barrett JS. Diversity in Pediatric
Dosing Guidance from Available Dosing Compendiums. J. Clin. Pharmacol 2004; 44: 1190
(Abstr. 21). .
Patel D, Narayan M, Collison KR, Nicholson C, Zuppa A, Barrett JS. Database Design and
Creation of a Pediatric Knowledgebase for Dosing Guidance and Research Decision Support. J.
Clin. Pharmacol 2004; 44: 1199 (Abstr. 62).
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS (cont.)
60.
Dimitriades C, Barrett JS, Zuppa A. Proposed pharmacokinetic model for transdermal
clonidine in children. J. Clin. Pharmacol 2004; 44: 1199 (Abstr. 60).
Skolnik J, Barrett JS, Shi H, and Adamson PC. Pre-clinical Studies in Support of the Clinical
Pharmacologic Evaluation of Actinomycin-D in Children with Cancer. J. Clin. Pharmacol 2004;
44: 1192 (Abstr. 31).
Mondick J and Barrett JS. A Physiologically-based Pharmacokinetic Model to Predict Tissue
Distribution of Actinomycin-D in Humans. J. Clin. Pharmacol 2004; 44: 1213 (Abstr. 117).
Mondick JT, Barrett JS, Eddington ND, Adamson PC. The Use of Simulation for Practical
Guidance on Early Leucovorin Rescue in Renally Impaired Patients Undergoing Methotrexate
Therapy. American Association of Pharmaceutical Scientists Meeting, Baltimore, MD,
November 3-6, 2004.
Sorenmo K, Samluk M, Clifford C, Baez J, Overley B, Skorupski K, Oberthaler K, Barrett J,
Van Winkle T, Seiler G, Poppenga R, Shofer F. Efficacy and toxicity of intracavitary
administration of pegylated liposomal encapsulated doxorubicin (Doxil) in dogs with
hemangiosarcoma. Veterinary cancer Society 24th Annual Conference, Proceedings, pg 66,
November 3-6, 2004, Kansas City, Missouri.
Nicholson III CE, Narayan M, Patel D, Vijayakumar S, Barrett JS. Multidisciplinary data
review and analysis to fulfill NIH data sharing requirements via S-PLUS server. American
Society of Clinical Pharmacology & Therapeutics Meeting, March, 2005.
Mondick JT, Barrett JS, Schall J, Mascarenhas M, Stallings VA. A Population
Pharmacokinetic Model for Pentadecanoic acid (PA) and Triheptadecanoic acid (THA)
Exposure Following Administration of a Malabsorption Blood Test (MBT) to Quantify
Steatorrhea. Presented, American Society of Clinical Pharmacology & Therapeutics Meeting,
March, 2005.
Yu JQ, Edwards K, Zhuang H, Alavi A, Barrett JS, Schall J, and Mascarenhas MR. Gastric
Emptying and Small Bowel Transit with a High Fat Content Meal. American Society of
Neuropsychopharmacology, December 12-16, 2004, San Juan, Puerto Rico.
Yu JQ, Zhuang H, Edwards K, Hernandez-Pampaloni M, Alavi A, Newberg A, Barrett JS,
Schall J, and Mascarenhas MR. High Fat Content Meal affects Gastric Emptying and Small
Bowel Transit. 52nd Society of Nuclear Medicine Annual Meeting, June 2005 in Toronto,
Canada.
Skolnik JM, Paccaly DA, Barrett JS, Adamson PC. Mechanisms to enhance enrollment in
pediatric trials: An in vitro procedure to clear residual chemotherapeutics from indwelling
catheters. J. Clin. Pharmacol 2005; 45: 1085 (Abstr. 76).
Barrett JS, Mondick JT, Skolnik J, Adamson PC. Clinical trial simulation in an academic
research setting: Engaging the clinical team and generating the simulation plan. J. Clin.
Pharmacol 2005; 45: 1087 (Abstr. 85).
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS (cont.)

71.
Mondick JT, Barrett JS, Widemann B, Cole D, Auton T, Adamson PC. A population
pharmacokinetic model to describe carboxypeptidase-G2 intervention in patients exhibiting
high-dose methotrexate-induced nephrotoxicity. J. Clin. Pharmacol 2005; 45: 1087 (Abstr. 84).
Narayan M, Barrett JS, Gupta M, Mondick JT, Patel D. Creation of the collaborative scientific
workbench (CSW) for multidisciplinary research. J. Clin. Pharmacol 2005; 45: 1090 (Abstr. 96).
Barrett JS, Vijayakumar K, Vijayakumar S, Mondick JT, Narayan M. NONMEM workbench:
A web-based tool for post-processing NONMEM output and automating NONMEM-based
analyses. J. Clin. Pharmacol 2005; 45: 1092 (Abstr. 106).
Gupta M, Robinson B, Felix C and Barrett JS. Strategies for assessment of drug combination
therapy: Response surface modeling of MTT assays to assess target agent synergy via cell
survival. J. Clin. Pharmacol 2005; 45: 1093 (Abstr. 107).

75. Lee JI, Wu D, and Barrett JS. Characterization of Silybin, Isosilybin, Silydianin and
Silychristin in Milk-Thistle Extracted by Liquid Chromatography-Electrospray Tandem Mass Spectrometry, Pittsburgh Conference, March 12-17, 2006. Su F, Nicolson SC, Adamson PC, Godinez R, Bayer CR, Barrett JS, Zuppa AF. The
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Infants Following Open
Heart Surgery. 35th Society of Critical Care Medicine Conference, February, 2006
Rege J.M, Robinson BW, Gupta M, Barrett JS, Adamson PC, Behling KC, Bantly AD, Moore
JS, Felix CA. "Pan-BCL-2 Family Small Molecule Inhibitor GX015-070 (GeminX, Inc.)
Exhibits Single Agent Cytotoxicity, is Synergistic with Select Anti-Leukemia Cytotoxic Agents,
and Induces Apoptosis in Cell Lines with t(4;11)(q21;q23) Translocations." Blood, Nov 2005;
106: 3368.
Skolnik JM, Lee J, Barrett JS and Adamson PC. A Novel Liquid Chromatography/Tandem
Mass Spectrometry Method for Quantifying Actinomycin-D and Vincristine in Children with
Cancer. Clin Pharmacol & Ther 79 (2) (2006),
Gupta M, Julian TN, Barrett JS. Development of a population pharmacokinetic model for
Genasense™ and its active metabolites. Clin Pharmacol & Ther 79 (2) (2006), PII-69, p. 54.
Gupta M, Wade KC, Jayaraman B, Mondick J, Barrett JS. Optimizing Fluconazole Dosing in
Preterm Neonates Based on Simulations from Posterior Parameter (Uncertainty) Distributions.
PAGE 15, Belgium, 2006
Mondick, JT, Gibiansky L, Gastonguay MR, Veal GJ, Barrett JS. Acknowledging Parameter
Uncertainty in the Simulation-Based Design of an Actinomycin-D Pharmacokinetic Study in
Pediatric Patients with Wilms’ Tumor or Rhabdomyosarcoma. PAGE Meeting, Belgium, 2006,
PAGE 15 (2006) Abstr 938 [www.page-meeting.org/?abstract=938]
Barrett JS, Vijayakumar K, Krishnaswami S, Gupta M, Mondick J, Jayaraman B, Muralidharan
A, Santhanam S, Vijayakumar S. iClinical: NONMEM Workbench. PAGE 15, Belgium, 2006,
PAGE 15 (2006) Abstr 1016 [www.page-meeting.org/?abstract=1016]
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS (cont.)

83.
Wade KC, Gupta M, Barrett JS, Adamson P. Considerations for Optimizing Fluconazole
Dosing in Preterm Neonates Based on Modeling and Simulation Approaches (ICAAC, PAS
Meeting, San Francisco, 2006)
Robinson BW, Behling KC, Barrett JS, Gupta M, Moore J, Bantly A, Kim J, Hii G, Willman
CL, Potter J, Adamson PC, Felix CA. Pre-clinical in vitro Evaluation of BCL-2 Antisense
Compound Genasense™ (G3139; Genta, Inc.) as a Targeted Pro-apoptotic Agent for Leukemias
with t(4;11)(q21;q23) Translocations. Blood, Nov 2005; 106: 3360.
Menon D, Thompson PA, Blaney SM, Adamson PC, Barrett JS. Population Pharmacokinetic
Model of Imatinib Mesylate and its Metabolite in Children. J. Clin. Pharmacol 46: 1095 (Abstr.
140), 2006
Skolnik JM, Vijayakumar S, Vijayakumar K, Narayan M, Patel D, Mondick J, Paccaly D,
Adamson PC, and Barrett JS. The creation of a clinically useful prediction tool for
methotrexate toxicity using real-time pharmacokinetic and pharmacodynamic modeling in
children with cancer. J. Clin. Pharmacol 46: 1093 (Abstr. 135), 2006
Barrett JS, Patel D, Skolnik J, Adamson P. Discrete Event Simulation (DES) as a Technique to
Study Decision Rule Efficiency in Event-Driven Clinical Deigns. J. Clin. Pharmacol 46: 1092
(Abstr. 131), 2006
Skolnik J, Patel D, Adamson PC, and Barrett JS. Increased efficiency in phase I trials:
improving trial design to expedite dosing guidance in pediatric oncology. J. Clin. Pharmacol
46: 1092 (Abstr. 130), 2006
Patel D, Narayan M, Skolnik J, Zuppa A, Wade K, Adamson P, Barrett JS. Construction of a
Physician-based Questionnaire to Assess Pediatric Pharmacotherapeutic Guidance and
Familiarity with Sources to Guide Dose Modification. J. Clin. Pharmacol 46: 1081 (Abstr. 85),
2006
Lee JI, Narayan M, Barrett JS. Separation, characterization and comparison of active
constituents in commercial standardized silymarin extracts and human plasma by liquid
chromatography–electrospray ionization mass spectrometry. J. Clin. Pharmacol 46: 1081
(Abstr. 87), 2006
Jayaraman B, Gupta M and Barrett JS. A SAS-based Solution to the Rapid Assembly,
Execution and Post-processing of NONMEM Jobs for Population-based Analyses. J. Clin.
Pharmacol
46: 1081 (Abstr. 84), 2006
Zuppa AF, Mondick JT, Barrett JS. A Pediatric Pharmacokinetic Model of Pentobarbital
Constructed from Historical Meta-data to Guide Prospective Trials in Critically-ill Children. J.
Clin. Pharmacol
46: 1080 (Abstr. 81), 2006
Wu D, Gupta M, Tuluc F, Lai J-P, Douglas S, Barrett JS. Modeling and Simulation Approach
to Identify Target Dose Range for Aprepitant in HIV Patients. J. Clin. Pharmacol 46: 1078
(Abstr. 75), 2006
J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS (cont.)

94.
Zuppa AF, Jayaraman B, Blumer J, Reed M, Barrett JS. Cross-institutional Drug Utilization in
Pediatric Intensive Care Units. J. Clin. Pharmacol 46: 1073 (Abstr. 53), 2006
Mondick JT , Schall JI, Barrett JS, Mascarenhas MR. The Effect of Timing of Pancreatic
Enzyme Replacement Therapy on Fat Absorption in Cystic Fibrosis as Assessed by the
Malabsorption Blood Test. 20th Annual North American Cystic Fibrosis Conference. Denver,
CO. November 2-5, 2006.
Zhang, AY, Robinson BW, Barrett JS, Willman CL, Felix CA. BCL-2:BH3-only pro-apoptotic
gene expression ratios correlate with in vitro sensitivity of primary MLL(+) infant acute
lymphoblastic leukemia to small molecule pan-BCL-2 family inhibitor GX15-070. Presented at
Annual AACR Meeting, April 17, 2007, Los Angeles, CA.
Menon D, Mondick JT, Jayaraman B, Cheung AT, Barrett JS. Pharmacokinetics /
Pharmacodynamics of Intravenous Bolus Nicardipine in Adults Undergoing Cardiovascular
Surgery. PAGE 16 (2007) Abstr 1186 [www.page-meeting.org/?abstract=1186]
Albers S, Meibohm B, Barrett JS, Mir TS, Laer S. Population Pharmacokinetics and Dose
Simulation of Carvedilol in Pediatric Patients with Congestive Heart Failure. PAGE 16 (2007)
Abstr 1102 [www.page-meeting.org/?abstract=1102]
Barrett JS, Skolnik J, Jayaraman B, Patel D, Adamson P. Improving Study Design and
Conduct Efficiency of Event-Driven Clinical Trials via Discrete Event Simulation: Application
to Pediatric Oncology. PAGE 16 (2007) Abstr 1075 [www.page-meeting.org/?abstract=1075]

100. Mitchell LG, Barrett JS, Cox P, Vegh P, Patel D, Castillo M, Massicotte P. Pharmacokinetics
and Dose-finding of Fragmin in Pediatric Patients at Risk for Thromboembolic Events. International Society for Thrombosis and Haemostasis Meeting, July 6-12, 2007, Geneva
101. Jayaraman B, Skolnik JM, Patel D and Barrett JS. SAS-based Discrete Event Simulation (DES)
to Evaluate Pediatric Oncology Phase I Trial Designs. J Clin Pharmacol 47(9): 1203, (Abstr 87), 2007
102. Menon D, Mondick JT, Jayaraman B, Cheung AT and Barrett JS. Pharmacokinetics and
Pharmacodynamics of Intravenous Nicardipine in Anesthetized Cardiac Surgical Patients. J Clin Pharmacol 47(9): 1205, (Abstr 99), 2007
103. Zhang AY, Barrett JS, Beauparlant P, Shore G, Goulet D, Elbast W, and Felix CA. Modeling
and Simulation Approach to Advance Molecularly Targeted Pro-apoptotic Agents for Infant Leukemias. J Clin Pharmacol 47(9): 1209, (Abstr 112), 2007
104. Skolnik JM, Mondick JT and Barrett JS. A Population Pharmacokinetic Model for Vincristine
in Children with Cancer. J Clin Pharmacol 47(9): 1210, (Abstr 121), 2007
105. Zuppa AF, Nicolson, SC, Barrett JS, Kang D, Mondick JT. A Pharmacokinetic Study of
pentobarital in neonates, infants and children following open heart surgery. Published Dec. 07 CCM Journal, Presented Feb. 08 at SCCM Meeting, # 415, Honolulu, Hawaii. J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia

ABSTRACTS (cont.)

106. Su F, Nicholson SC, Adamson PC, Kang D, Barrett JS, Zuppa AF. A Phase 1 Trial and
Pharmacokinetic Study of Dexmedetomidne in Neonates following Open Heart Surgery. Published Dec. 07 CCM Journal, Presented Feb. 08 at SCCM Meeting, # 430, Honolulu, Hawaii.
107. Barrett JS. Enhancing Methotrexate Pharmacotherapy in Children with Cancer: A Decision
Support System Integrating Real-time PK/PD Modeling and Simulation with Patient Medical Records. Japanese Journal of Therapeutic Drug Monitoring 25(3), supplement: s36-7, 2008.
108. Su F, Nicolson SC, Barrett JS, Adamson PC, Kang DS, Godinez R and Zuppa AF. Population
Pharmacokinetics of Dexmedetomidine in Infants Following Open Heart Surgery. J Clin Pharmacol 48(9):1122 (Abstr 102), 2008
109. Su F, Nicolson SC, Adamson PC, Kang D, Barrett JS, and Zuppa AF. A Phase I Trial and
Pharmacokinetic Study of Dexmedetomidine in Neonates Following Open Heart Surgery. J Clin Pharmacol 48(9):1122 (Abstr 103), 2008
110. Jayaraman B and Barrett JS. A SAS-based Query and Exploitation Interface to Hospital Drug
Utilization Data. J Clin Pharmacol 48(9):1121 (Abstr 98), 2008
111. Narayan M, Patel D, and Barrett JS. Health Care Attitudes and Trends Among the Pediatric
Prescribing Community. J Clin Pharmacol 48(9):1126 (Abstr 118), 2008
112. Barrett JS, Patel D, Jayaraman B, Narayan M, and Zuppa AF. Key Performance Indicators to
Assess Pediatric Pharmacotherapeutic Guidance. J Clin Pharmacol 48(9):1108 (Abstr 42), 2008
113. Zhang AY, Barrett JS, Danet-Desnoyers G, Secreto A, Nguyen VT, Keefer C, Shan X, Bunte
R, Lavoie M, Beauparlant P and Felix CA. Obatoclax Biodistribution in MLL Leukemia NOG Mouse Model is Predicted By Modeling and Simulation and Shows High Tissue Penetration at Clinically Important Sites. J Clin Pharmacol 48(9):1130 (Abstr 134), 2008
114. Cummings E, Jayaraman B, Mondick J and Barrett JS. Determination of Operating
Characteristics and Performance Requirements for a Methotrexate Decision Support in Pediatric Oncology Patients. J Clin Pharmacol 48(9):1106 (Abstr 34), 2008
115. Barrett JS, Mitchell LG, Patel D, Cox P, Vegh P, Castillo M, and Massicotte P. A Population-
based Analysis of Dalteparin Pharmacokinetics in Pediatric Patients at Risk for Thromboembolic Events. J Clin Pharmacol 48(9):1107 (Abstr 38), 2008
116. Barrett JS, Adamson PC, Narayan M, Zuppa AF, Skolnik JM, Mondick JT, Norris R, Wade K,
Jayaraman B, Patel D, Cummings E, Vijayakumar K, and Vijayakumar S. Pediatric Knowledgebase (PKB) -- A Hospital-based, Decision Support System to Guide Pharmacotherapy. J Clin Pharmacol 48(9):1108 (Abstr 41), 2008
117. Barrett JS, Vijayakumar K, Vijayakumar S, Patel D, Narayan M, Jayaraman B, Cummings E
and Douglas SD. Managing Disparate Data Generated from Translational Research Activities: iClinical Implementation to Support Data Integration and Sharing for the IPCP. J Clin Pharmacol 48(9):1126 (Abstr 120), 2008 J.S. Barrett, Ph.D., FCP
Research Associate Professor, Pediatrics, University of Pennsylvania
Director, Laboratory for Applied PK/PD, Children's Hospital of Philadelphia


118. Marsteller DA, Douglas SD, Wu D, and Barrett JS. Potential for Achieving Therapeutic
Aprepitant Exposure in HIV-Infected Patients Through CYP3A4 Interaction with Ritonavir. J Clin Pharmacol 48(9):1123 (Abstr 104), 2008
119. Comisar CM, Jayaraman B and Barrett JS. Evaluation of Published Vancomycin
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120. Fossler M, Alonzo T, Beyene J, Gamis A, Aplenc R and Barrett JS. Trial Outcome Simulations
Evaluating “Pick the Winner Strategy” to Support New Candidate Screening in Myeloid Leukemia. J Clin Pharmacol 48(9):1124 (Abstr 109), 2008
121. Marsenic O, Zuppa AF, Barrett JS, and Pfister M. Application of Individualized Bayesian Urea
Kinetic Modeling (IBUKM) to Pediatric Hemodialysis. J Clin Pharmacol 48(9):1126 (Abstr 119), 2008
122. Wu D, Kraft WK, Ehrlich ME and Barrett JS. Sublingual Bioavailability of Buprenorphine in
Newborns with Neonatal Abstinence Syndrome- A Case Study on Physiological and Developmental Changes Using SIMCYP. J Clin Pharmacol 48(9):1127 (Abstr 123), 2008
123. Rowan C, Brinker AD, Nourjah P, Chang J, Mosholder A, Barrett JS, and Avigan M.
Rhabdomyolyis Reports Show Interaction Between Simvastatin and CYP3A4 Inhibitors. J Clin Pharmacol 48(9):1115 (Abstr 71), 2008

Source: http://www.bit.edu.cn/docs/20091012202752650130.pdf

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