【优质】HowNewInsightsintoPharmacogenomicsLeadtoRev.pptVIP

S-M Huang, Showa Univ., 8/3/98 Shiew-Mei Huang January 24, 2003 How New Insights into Pharmacogenomics Lead to Revisions of Product Labels Shiew-Mei Huang, Ph.D. Deputy Director for Science Office of Clinical Pharmacology Biopharmaceutics CDER, FDA huangs@ 21 CFR 201.57 “…if evidence is available to support the safety and effectiveness of the drug only in selected subgroups of the larger population with a disease, the labeling shall describe the evidence and identify specific tests needed for selection or monitoring of patients who need the drug.” ADR PM EM decreased appetite 23% 16% insomnia 13% 7% sedation 4% 2% depression 6% 2% tremor 4% 1% early morning awakening 3% 1% pruritus 2% 1% mydriasis 2% 1% * * Advisory Committee for Pharmaceutical Science -Clinical Pharmacology Subcommittee- November 14, 2005 Rockville, MD Drug and Biologics/Device Labeling Recommendations- [Section] [Content] Topic 1A backgrounder: /ohrms/dockets/ac/05/briefing/2005-4194B1_00_TOC.htm All clinically relevant information on effect of polymorphic variation in drug metabolizing enzymes, transporters, receptors and/or other proteins on pharmacokinetics, pharmacodynamics, clinical responses (both safety and efficacy) Clinical Studies Section Clinical Pharmacology Section OR When the information has important implications for safe and effective use, the consequences of the genetic differences and/or recommendations may be placed in Indications and Usage AND/ OR Dosage Administration Precautions/ Warnings Contra- indications Boxed Warning Clinical Studies Adverse Reactions HIGHLIGHTS Laboratory Testing If a drug is indicated only for a population with a certain genetic makeup, and a genotypic or phenotypic test needs to be conducted prior to prescription and administration Example: Herceptin Trastuzumab (Herceptin) INDICATIONS USAGE indicated for..metastatic breast cancer whose tumor overexpress the HER2