Introduction to the Pediatric PPK (PD) Study Design Template by kmb15358

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									  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.
      Director, Office of Clinical Pharmacology and
                    Biopharmaceutics
       Center for Drug Evaluation and Research
             Food and Drug Administration
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
      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)
  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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