Clinical Pharmacology Subcommittee of the


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.

10:15 Break

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

1:00 Lunch

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

3:00 Break

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.