美國(guó)食品藥品監(jiān)督管理局（FDA）于2023年4月發(fā)布了“評(píng)估簡(jiǎn)化新藥申請(qǐng)仿制透皮和局部給藥系統(tǒng)可能的刺激性和致敏性的供企業(yè)用的指導(dǎo)原則草案”，全面而又具體地闡明FDA對(duì)仿制透皮和局部給藥系統(tǒng)（TDS）可能的刺激性和致敏性人體內(nèi)研究的設(shè)計(jì)和實(shí)施的建議。其中包括一般原則（一般考慮）、研究設(shè)計(jì)和實(shí)施、統(tǒng)計(jì)分析（刺激性分析和致敏性分析）、輔料TDS和陽(yáng)性對(duì)照TDS以及部分（切割）TDS等。而中國(guó)目前還沒(méi)有類(lèi)似的指導(dǎo)原則，詳細(xì)介紹FDA該指導(dǎo)原則主要內(nèi)容，期望對(duì)中國(guó)仿制TDS刺激性和致敏性人體內(nèi)研究與監(jiān)管有所裨益。

The Assessing the Irritation and Sensitization Potential of Generic Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry released by the FDA in April 2023, comprehensively and specifically clarified the FDA's recommendations for the design and conduct of in vivo studies on the potential irritation and sensitization of generic transdermal and local drug delivery systems. This includes general principles (general considerations), study design and conduct, statistical analyses (irritation analysis and sensitization analysis), vehicle TDS and positive control TDS, as well as partial (Cut) TDS. However, there is currently no similar guidance in China. This article provides a detailed introduction to the FDA's guidance, with the expectation of being beneficial for the study and regulation of the irritation and sensitization of generic transdermal and local drug delivery systems in China.

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