Clinical Pharmacology Subcommittee of the
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
CDER Advisory Committee Conference Room
5630 Fishers Lane, Rockville, MD
October 23, 2002
8:00 Call to Order William Jusko, Ph.D., Acting Chair
Conflict of Interest Kathleen Reedy, Executive Secretary
8:10 Welcome Helen Winkle, Acting Director OPS
8:15 Introduction to Meeting Lawrence Lesko, Ph.D., Director OCBP
Topic # 1: Consideration of investigational pharmacokinetic studies to identify patient populations at risk: Methods used to adjust dosing given the availability of exposure-response information
8:45 FDA presentation: case studies and a model for the future: Peter Lee, Ph.D.
9:45 Evaluation of methods and clarifying questions: Richard LaLonde, Pharm.D..
Lewis Sheiner, Ph.D.
10:30 Committee discussion
11:30 Using exposure-response relationships to define therapeutic index:
a preliminary approach based on utility function: Jurgen Venitz, M.D.
12:00 Open Public Hearing
Topic # 2: Use of exposure-response relationships in the Pediatric Study
Decision Tree: Questions to be asked using the FDA pediatric database
2:00 Introduction Arzu Selen, Ph.D.
2:10 Medical and clinical pharmacology perspective on the pediatric study decision tree and experience to date:
Rosemary Roberts, Ph.D.
2:30 Committee Discussion
Topic # 3: Scientific and practical considerations in the use of pharmacogenetic tests to determine drug dosage and administration
3:15 Current experience and clinical pharmacology perspective:
Questions to the committee Lawrence Lesko, Ph.D.
3:45 Assessment of TPMT testing and impact on risk management:
Richard Weinshilboum, Ph.D.
Mary Relling, Pharm.D.
4:00 Committee discussion
4:30 Concluding Remarks Lawrence Lesko, Ph.D.
5:00 Adjourn William Jusko, Ph.D.