Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies

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