Lin Zhongping John, Li Wenkui, Weng Naidong
Frontage Laboratories, Inc., 105 Great Valley Parkway, Malvern, PA 19355, USA.
Bioanalysis. 2011 Jan;3(1):57-66. doi: 10.4155/bio.10.168.
With the globalization of drug development activities, transferring a validated bioanalytical procedure to a different site within a pharmaceutical company, or to one or multiple contract research organizations has been dramatically increased in recent years. Undeniably, bioanalytical method transfer is the needed step prior to routine sample analysis at the receiving laboratory. It is clearly stated in the 2001 US FDA Guidance on Bioanalytical Method Validation that a partial validation is needed for method transfer between laboratories. In the current EMA draft guidelines on method validation, the necessity of a method transfer is also emphasized. However, the above guidelines do not give many details on how and when a method transfer validation should be conducted. There is a need for a step-by-step deliberation on the overall strategies, procedures and even technical details for a successful bioanalytical method transfer. In this article, we review the contemporary information available in the scientific literature on method transfer and illustrate various bioanalytical method transfer scenarios using case studies. A 'flexible and fit-for-purpose' bioanalytical method transfer strategy is proposed.
随着药物研发活动的全球化，近年来，将经过验证的生物分析方法转移至制药公司内部的不同地点，或转移至一个或多个合同研究组织的情况显著增加。不可否认，生物分析方法转移是接收实验室进行常规样品分析之前的必要步骤。2001年美国食品药品监督管理局（US FDA）关于生物分析方法验证的指南明确指出，实验室间的方法转移需要进行部分验证。在当前欧洲药品管理局（EMA）关于方法验证的指南草案中，也强调了方法转移的必要性。然而，上述指南并未详细说明应如何以及何时进行方法转移验证。需要对成功进行生物分析方法转移的总体策略、程序甚至技术细节进行逐步审议。在本文中，我们回顾了科学文献中关于方法转移的当代信息，并通过案例研究说明了各种生物分析方法转移的情况。我们提出了一种“灵活且适用”的生物分析方法转移策略。
