Bioavailability/bioequivalence
Executive Summary
FDA's Pharmaceutical Science Advisory Committee will meet on Oct. 22 to discuss bioavailability/bioequivalence issues related to solid oral dosage forms; progress reports on guidances pertaining to the biopharmaceutical classification system, other BA/BE guidances; and criteria (average, population, and individual) to allow comparison of BE measures/parameters. The Oct. 22-23 meetings will begin at 8:30 a.m. and be held in the CDER conference room at 5630 Fishers Lane, Rockville, Md
FDA's Pharmaceutical Science Advisory Committee will meet on Oct. 22 to discuss bioavailability/bioequivalence issues related to solid oral dosage forms; progress reports on guidances pertaining to the biopharmaceutical classification system, other BA/BE guidances; and criteria (average, population, and individual) to allow comparison of BE measures/parameters. The Oct. 22-23 meetings will begin at 8:30 a.m. and be held in the CDER conference room at 5630 Fishers Lane, Rockville, Md. |