ANALYTICAL METHODS VALIDATION - BIOAVAILABILITY, BIOEQUIVALENCE AND PHARMACOKINETIC STUDIES - CONFERENCE REPORT

This is a summary report of the conference on Analytical Methods Valid ation: Bioavailability, Bioequivalence and Pharmacokinetic Studies. Th e conference was held from December 3 to 5, 1990 in the Washington, DC area and was sponsored by the American Association of Pharmaceutical Scientists, US Food and Drug Administration, Federation International Pharmaceutique, Health Protection Branch (Canada) and Association of O fficial Analytical Chemists. The purpose of the report is to represent our assessment of the major agreements and issues discussed at the co nference. The report is also intended to provide guiding principles fo r validation of analytical methods employed in bioavailability, bioequ ivalence and pharmacokinetic studies in man and animals. The objective s of the conference were: 1. To reach a consensus on what should be re quired in analytical methods validation and the procedures to establis h validation; 2. To determine processes of application of the validati on procedures in the bioavailability, bioequivalence and pharmacokinet ic studies; 3. To develop a report on analytical methods validation (w hich may be referred to in developing future formal guidelines). Accep table standards for documenting and validating analytical methods with regard to processes, parameters or data treatments were discussed bec ause of their importance in assessment of pharmacokinetic, bioavailabi lity and bioequivalence studies. Other topics which were considered es sential in the conduct of pharmacokinetic studies or in establishing b ioequivalency criteria, including measurement of drug metabolites and stereoselective determinations, were also deliberated.