美國食品藥品管理局（FDA）于2023年4月發(fā)布了“簡化新藥申請(qǐng)的透皮和局部給藥系統(tǒng)（TDS）黏附性評(píng)估的供企業(yè)用指導(dǎo)原則草案”，修訂了2018年公布的同名指導(dǎo)原則草案。該修訂的指導(dǎo)原則草案包括前言、背景、黏附性的評(píng)價(jià)、黏附性和生物等效性的綜合評(píng)價(jià)以及數(shù)據(jù)提交格式5部分。重點(diǎn)討論了仿制TDS黏附性的臨床評(píng)價(jià)，包括其研究設(shè)計(jì)和實(shí)施以及統(tǒng)計(jì)分析。中國目前還沒有類似的指導(dǎo)原則，詳細(xì)介紹FDA的該指導(dǎo)原則草案，期望對(duì)我國仿制的TDS的黏附性評(píng)估的臨床研究和藥品監(jiān)管部門的審評(píng)有幫助。

The US Food and Drug Administration (FDA) released Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry in April 2023. This draft guidance revised the draft guidance with the same name published in 2018. The revised draft guidance include five parts: introduction, background, evaluation of adhesion, combined evaluation of adhesion and bioequivalence, and format of data submission. The focus was on the clinical evaluation of the adhesion of generic TDS, including its study design and conduct, as well as statistical analysis. At present, there is no similar guidance in China. This article provides a detailed introduction to the FDA's draft guidance, hoping to be helpful for clinical research and review by drug regulatory authorities on the adhesion evaluation of generic TDS in China.

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