生物等效性试验中生物分析的关键问题

Key questions in bioanalysis in bioequivalence study

生物等效性试验是药品研发和评价的一个重要内容。生物等效性试验首选药动学研究的方法,药动学研究则必然涉及到生物分析,因此生物分析对于生物等效性试验具有举足轻重的作用,其结果的可靠性将直接影响生物等效性试验的质量。但我国目前却没有完整、独立的生物分析方面的指导原则。基于上述原因,我们根据国内外的相关指导原则,并尽可能结合我们的实际工作,探讨生物等效性试验中生物分析需注意的关键问题。

Bioequivalence study is an important aspect of medicinal product development and evaluation. Pharmacokinetic method, as the most preference used to evaluate bioequivalence, necessarily involves measurement of drug concentrations in biological matrices, which is bioanalysis. The reliability of bioanalysis results directly affects the quality of bioequivalence study. However, there is no complete and specialized guidance related to bioanalysis issued in China. Therefore, in this paper, several key questions in bioanalysis in bioequivalence study were discussed based on related guidelines and our experiences.