ANALYTICAL METHODS VALIDATION - BIOAVAILABILITY, BIOEQUIVALENCE, AND PHARMACOKINETIC STUDIES

This is a summary report of the conference on "Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies." The conference was held from December 3 to 5, 1990, in the Washington, D.C., area and was sponsored by the American Association of Pharmaceutical Scientists, the U.S. Food and Drug Administration, Federation International Pharmaceutique, Health Protection Branch (Canada), and the Association of Official Analytical Chemists. The report presents our assessment of the major agreements and issues discussed at the conference. The report is also intended to provide guiding principles for validation of analytical methods used in bioavailability, bioequivalence, and pharmacokinetics studies in humans and animals. The objectives of the conference were as follows: (1) to reach a consensus on what should be required in analytical methods validation and the procedures to establish validation; (2) to determine processes of application of the validation procedures in bioavailability, bioequivalence, and pharmacokinetics studies; and (3) to develop a report on analytical methods validation that may be referred to in developing future formal guidelines. Acceptable standards for documenting and validating analytical methods with regard to processes, parameters, or data treatments are discussed because of their importance in assessing pharmacokinetic, bioavailability, and bioequivalence studies. Other topics that were considered essential in the conduct of pharmacokinetic studies or in establishing bioequivalency criteria, including measurement of drug metabolites and stereoselective determinations, are also discussed.