兩階段生物等效性研究目前已得到多個國家生物等效性指南的認(rèn)可，但在實施兩階段生物等效性研究時如何在控制I類錯誤的基礎(chǔ)上保證目標(biāo)把握度是很大的挑戰(zhàn)。對目前國內(nèi)外文獻(xiàn)發(fā)表的兩階段設(shè)計生物等效性研究方法加以綜述，詳細(xì)介紹了文獻(xiàn)方法的研究策略、檢驗水準(zhǔn)的校正方法、樣本量再估算等，為國內(nèi)藥品申辦者在開展兩階段生物等效性研究提供參考。

Two-stage designs for the assessment of bioequivalence have been recently accepted in various regulatory authorities. However, controlling type I error rates around 5% at targeted power is still a great challenge for applying two-stage method. This paper reviewed the feature of present designs of the two-stage bioequivalence. The decision tree, nominal significance level, and sample size recalculation in previously published methods were also introduced in detail, which would be referential for domestic sponsors in the study of two-stage design bioequivalence.

國家自然科學(xué)基金面上項目（81173134）；安徽省衛(wèi)生廳醫(yī)學(xué)科研重點項目（2010A013）