美國(guó)食品藥品管理局（FDA）于2018年5月發(fā)布了“考慮列入OTC專論的外用藥活性成分的最大用量試驗(yàn)：研究要點(diǎn)和考慮的因素供企業(yè)用的指導(dǎo)原則”。最大用量試驗(yàn)（MUsT）是評(píng)估外用藥體內(nèi)生物利用度的標(biāo)準(zhǔn)方法，該指導(dǎo)原則對(duì)MUsT許多研究要點(diǎn)提出了具體的建議。詳細(xì)介紹該指導(dǎo)原則的主要內(nèi)容，期待對(duì)我國(guó)這方面的研究和監(jiān)管有益。

FDA issued Maximal Usage Trialsfor Topical Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph:Study Elements and Considerations Guidance for Industry in May 2018. Maximal usage trial (MUsT) is a standard approach to assess the in vivo bioavailability of topical drug products.The guidance provides specific suggestions for many study elements of MUsT. This paper introduces the main contents of the guidance in detail, and expects to be beneficial to the research and supervision of this aspect in China.