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Lawrence J. Lesko, Ph.D. Director, Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation and R

Introduction to the Pediatric PPK (PD) Study Design Template and Analyses of the FDA Pediatric Database Clinical Pharmacology Subcommittee Advisory Committee for Pharmaceutical Sciences April 22-23, 2003 Rockville, Maryland. Lawrence J. Lesko, Ph.D.

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Lawrence J. Lesko, Ph.D. Director, Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation and R

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  1. Introduction to the Pediatric PPK (PD) Study Design Template and Analyses of the FDA Pediatric DatabaseClinical Pharmacology SubcommitteeAdvisory Committee for Pharmaceutical SciencesApril 22-23, 2003Rockville, Maryland Lawrence J. Lesko, Ph.D. Director, Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation and Research Food and Drug Administration

  2. Pediatric Rule or Best Pharmaceuticals for Children Act • Use adult clinical data to draw conclusions about the efficacy, safety and dosing of drugs in pediatric patients • avoids large scale pediatric clinical trials • basis to decide what studies to conduct • expedites access to drugs for children • cost-effective • generally successful in meeting goals

  3. Some Questions Always Need Assessment • Is it reasonable to assume a similar PK-PD relationship as adults • need to develop standard methods for specific drugs and drug classes • What is the appropriate dose? • rely on PK studies • full exposure profiles or sparse samples • dosing intended to achieve exposure similar to adults • standardized PPK study design template would be useful (Dr. Peter Lee)

  4. What Can Be Learned From the Studies Conducted Under the Pediatric Rule? • Evaluation of the FDA pediatric database • age groups, PK data, elimination pathways, clinical endpoints • Presentation of research objectives to generate knowledge from database • look at the underlying mechanisms (age-related) where exposure differences exist between children and adults • goal is to improve or revise the pediatric decision tree to better identify studies need in children • Dr. Gene Williams

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