Food and Drug Administration

Advisory Committee for Pharmaceutical Sciences

Clinical Pharmacology Subcommittee

April 22, 2003


Introduction to the Meeting, Dr. Lawrence Lesko, PhD, FDA (HTM) (PPT)

Quantitative Risk Analysis Using Exposure-Response for Determining Dose Adjustment for Special Populations, Dr. Peter Lee, PhD, FDA (HTM) (PPT)

Quantitative Risk/Benefit Analysis in Regulatory Decision making, B. Nguyen, Patrick Marroum & Joga Gobburu, FDA (HTM) (PPT)

Application of Exposure Response Relationship for Dose Adjustment, Dr. Jenny Zheng, PhD, FDA (HTM) (PPT)

Population Approach for Clinical Drug Safety Assessment in Regulatory Decisions, Dr. He Sun, PhD, FDA (HTM) (PPT)

Optimizing Dosing Strategies for Defined Therapeutic Targets, Mats Karlsson & Sive Jönsson, Uppsala University, Sweden (HTM) (PPT)

Introduction to the Pediatirc PPK (PD) Study Design Template and Analyses of the FDA Pediatric Database, Dr. Lawrence Lesko, PhD, FDA (HTM) (PPT)

Pediatric Population Pharmacokinetics Study Design Template, Dr. PeterLee, PhD, FDA (HTM) (PPT)

Modeling Pediatric Systemic Drug Clearance as a Function of Child Age, Adult Pharmacokinetics and In-Vitro Microsomal Metabolism, Dr. Gene Williams, PhD, FDA (HTM) (PPT)