生物等效性试验的重要环节和注册核查关键点

Important factors of bioequivalence study and its key points of on-site inspection for drug registration

我国是仿制药注册申请大国,每年生物等效性(BE)试验注册核查任务繁重。如何优化检查方法,提高检查效率和质量,是目前BE试验注册核查面临的一个挑战。本文主要基于药代动力学研究的BE试验,对其重要环节和注册核查关键点进行探讨,希望对临床试验参与各方以及BE试验注册核查提供有益参考。

China is a big country of generic drug registration application, with a considerable number of yearly on-site inspection tasks of bioequivalence study for drug registration. How to improve the efficiency and quality of inspection becomes a challenge for on-site inspection of drug registration about bioequivalence study. In this paper, the important factors of pharmacokinetics-based bioequivalence study and its key points of on-site inspection for drug registration have been discussed. The purposes are to provide useful references for all parties involved in bioequivalence study and for on-site inspection for drug registration.