美國(guó)食品藥品監(jiān)督管理局（FDA）于2015年6月發(fā)布了《藥物雄性介導(dǎo)發(fā)育毒性風(fēng)險(xiǎn)評(píng)估指導(dǎo)原則》（草案），闡述了當(dāng)前FDA對(duì)男性人群使用藥物后產(chǎn)生的潛在相關(guān)發(fā)育毒性風(fēng)險(xiǎn)評(píng)估的策略與方法，拓展了對(duì)傳統(tǒng)雄性生殖與發(fā)育毒性的認(rèn)識(shí)與評(píng)價(jià)。該指導(dǎo)原則對(duì)于指導(dǎo)研究者進(jìn)行藥物臨床和非臨床雄性生殖與發(fā)育毒性評(píng)價(jià)具有重要意義，而我國(guó)目前對(duì)此類毒性風(fēng)險(xiǎn)尚未特殊關(guān)注。簡(jiǎn)介該指導(dǎo)原則主要內(nèi)容，以供研究者參考。

FDA issued Assessment of Male-Mediated Developmental Risk for Pharmaceuticals Guidance for Industry (draft) in June 2015. This guidance provides strategies and methods for assessing risks to embryo/fetal development resulting from administration of an investigational active pharmaceutical ingredient (API) to males and expanding the traditional recognizing for male reproductive and developmental toxicity. This guidance is of great significance to guide the clinical and non-clinical studies on evaluation of male reproductive and developmental toxicity. However, in China, male-mediated developmental risk has not yet been concerned specially. This article introduces the guidance to provide recommendations for researchers.

浙江省科技計(jì)劃項(xiàng)目（2014F30018）