生物样品方法学验证-综述.docVIP

Workshop/ConferenceReport Bioanalytical Method Validation—ARevisit with a Decade of Progress Vinod P. Shah, 1Kamal K. Midha, 2,19John W. A. Findlay, 3Howard M. Hill, 4James D. Hulse, 5Iain J. McGilveray, 6Gordon McKay, 2Krys J. Miller, 7 Rabindra N. Patnaik, 1Mark L. Powell, 8Alfred Tonelli, 9C. T. Viswanathan, 1and Avraham Yacobi 10 Received July 31, 2000; accepted September 14, 2000 PURPOSE OF THE REPORT This report is a synthesis of (1the earlier conference on Analytical Methods Validation?Bioavailability,Bioequiva-lence and Pharmacokinetic Studies (Conferenceheld in Ar-lington, VA, December 3–5,1990and the report published in Pharmaceutical Research, 9:588-592, 1992 and (2the work-shop on “BioanalyticalMethods Validation—ARevisit with a Decade of Progress,”(Workshopheld in Arlington, VA, January 12–14,2000, sponsored by the American Associa-tion of Pharmaceutical Scientists and the U. S. Food and Drug Administration. The bioanalytical method validation work-shop of January 12–14,2000was directed towards small mol-ecules. A separate workshop was held in March 1–3,2000to discuss validation principles for macromolecules. The pur-pose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop. The re-port is also intended to provide guiding principles for valida-tion of bioanalytical methods employed in support of bio-availability, bioequivalence, and pharmacokinetic studies in man and in animals. OBJECTIVES The objectives of the conference and the workshop were as follows: ●To agree on what should be required in bioanalytical method validation and the procedures to establish vali-dation. ●To determine processes of application of the valida-tion procedures in bioavailability, bioequivalence and pharmacokinetics studies. ●To review the progress, impact and advances made during the last decade of bioanalyt