Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies

摘要: 0 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, US. 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. ___ -. ~. ~ _ quantitative determination drugs biological samples play significant role evaluation interpretation data. It use well-characterized fully validated yield reliable results can satisfactorily interpreted. techniques constantly being changed improved; many instances, these cutting edge technology. important emphasize each technique has its own characteristics, which will vary drug. Moreover, appropriateness influenced ultimate objective study. Specific criteria needed analysis analyte (drug and/or metabolite). Although method independent those other methods, there situations comparison necessary (e.g., when more than one been long-term study). When sample conducted site, it validate methodb) site appropriate information different sites interlaboratory reliability. Unless regular basis, providing confidence continued validity, document still valid before Adequate not basis often consists running standard curve new quality-control show responses, relationship, general characteristics similar previous valida-