Performance Improvement 2001. Drug Metabolism: Drug-Drug Interactions


Recent examples of studies that have provided information to specific review decisions include: (1) interactions and metabolism studies of anti-cancer drugs such as paclitaxel, (2) anti-abuse drugs such as LAAM, (3) anti-HIV drugs such as the protease inhibitors, (4) anti-epileptic drugs, (5) cardiovascular drugs, and (6) anti-malarial drugs. In addition to the general technical expertise brought to bear on these problems, results from the program have been incorporated into final product labeling for some drugs, including paclitaxel and saquinavir. Labeling changes for other drugs are under discussion. Also, cutting- edge issues regarding cases of intermediate potency for cytochrome P450 pathways are under investigation.


AGENCY SPONSOR: Center for Drug Evaluation and Research

FEDERAL CONTACT: Jerry Collins, 301-427-1065

PIC ID: 7103

PERFORMER: Food and Drug Administration, Rockville MD