ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

Clinical Pharmacology Subcommittee

CDER Advisory Committee Conference Room

October 23, 2002

5630 Fishers Lane

Rockville, MD

8:00 Call to Order William Jusko, Ph.D., Acting Chair

Conflict of Interest Kathleen Reedy, Exec.Sec.

8:10 Welcome Helen Winkle, Acting Director OPS

8:15 Introduction to Meeting Lawrence Lesko, Ph.D., Director OCBP

8:45 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, M.D., Ph.D.

(10:15 -10:30 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., Ph.D.

12:00 Open Public Hearing

1:00 Lunch

2:00 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, M.D.

2:30 Committee Discussion

3:00 Break

3:15 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.

3:30 Assessment of TPMT testing and
impact on risk management Richard Weinshilboum, M.D.
Mary Relling, Pharm.D.

4:30 Concluding Remarks Lawrence Lesko, Ph.D.

5:00 Adjourn William Jusko, Ph.D.