Shah V P, Midha K K, Dighe S, McGilveray I J, Skelly J P, Yacobi A, Layloff T, Viswanathan C T, Cook C E, McDowall R D
College of Pharmacy, University of Saskatchewan, Saskatoon, Canada.
Eur J Drug Metab Pharmacokinet. 1991 Oct-Dec;16(4):249-55. doi: 10.1007/BF03189968.
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, 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 Official Analytical Chemists. The purpose of the report is to represent 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 employed in bioavailability, bioequivalence and pharmacokinetic studies in man and animals. The objectives of the conference were: 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 the bioavailability, bioequivalence and pharmacokinetic studies; 3. To develop a report on analytical methods validation (which 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 were discussed because of their importance in assessment of pharmacokinetic, bioavailability and bioequivalence studies. Other topics which were considered essential in the conduct of pharmacokinetic studies or in establishing bioequivalency criteria, including measurement of drug metabolites and stereoselective determinations, were also deliberated.
这是一份关于“分析方法验证：生物利用度、生物等效性和药代动力学研究”会议的总结报告。该会议于1990年12月3日至5日在华盛顿特区地区举行，由美国药物科学家协会、美国食品药品监督管理局、国际药学联合会、加拿大卫生保护局和官方分析化学家协会共同主办。本报告旨在呈现我们对会议上讨论的主要共识和问题的评估。该报告还旨在为人体和动物生物利用度、生物等效性及药代动力学研究中所采用分析方法的验证提供指导原则。会议的目标如下：1. 就分析方法验证的要求以及建立验证的程序达成共识；2. 确定验证程序在生物利用度、生物等效性和药代动力学研究中的应用流程；3. 编写一份关于分析方法验证的报告（可作为制定未来正式指南的参考）。由于其在药代动力学、生物利用度和生物等效性研究评估中的重要性，会议讨论了关于分析方法在过程、参数或数据处理方面记录和验证的可接受标准。还审议了在进行药代动力学研究或建立生物等效性标准时其他被认为至关重要的主题，包括药物代谢物的测量和立体选择性测定。
