Advisory Committee for Pharmaceutical Science

Clinical Pharmacology Subcommittee

Meeting October 23, 2002


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.

Topic # 2 Use of exposure-response relationships in the Pediatric Study Decision Tree: Questions to be asked using the FDA pediatric database

D. McCarver and R. Hines. The ontogeny of human drug-metabolizing enzymes: Phase II conjugation enzymes and regulatory mechanisms. JPET 300:361-366, 2002.

Hines, R. and D. McCarver. The ontogeny of human drug-metabolizing enzymes: Phase I oxidative enzymes. JPET 300:355-360, 2002.

Topic # 3 Scientific and practical considerations in the use of pharmacogenetic tests to determine drug dosage and administration.

Lesko, L and J. Woodcock. Pharmacogenomic-guided drug development: Regulatory perspective. The Pharmacogenomics Journal. 2(1) 18-22. 2002.

McLeod, H. The thiopurine S-methyltransferase gene locus - implications for clinical pharmacogenomics. Pharmacogenomics 3 (1), 89-98. 2002.