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本文介绍了葛兰素威康研究实验室药物代谢研究部门对生物分析方法进行确认的策略。阐述了设计一个恰当生物分析方法的基本原理，以及建立一个适当的方法之前必须对实验数据进行评估，评估参数包括选择性、专属性、定量检出限、线性、准确度、精密度和回收率等。本文还讨论了药物各发展阶段确认设计前必须考虑的一些要点，如生物基质、分析工作标准、样品分批量大小及组成、分析仪器、初始方法确认、临床前方法确认、临床方法确认、方法转让、研究中的监测等。
This article describes strategies for identifying bioanalytical methods in the Department of Drug Metabolism at GlaxoSmithKline Research Laboratories. The rationale for designing an appropriate bioanalytical method is described and experimental data must be evaluated prior to establishing an appropriate method. The evaluation parameters include selectivity, specificity, quantitation, linearity, accuracy, precision, and recovery Wait. This article also discusses the key points that must be considered before design validation at various stages of drug development, such as biological matrices, analytical work standards, size and composition of sample batches, analytical instruments, initial method validation, preclinical validation, clinical validation, method assignment , Research monitoring and more.