美國(guó)食品藥品管理局于2015年10月發(fā)布了“改變劑型和改變給藥途徑藥品非臨床安全性評(píng)價(jià)指導(dǎo)原則”,包括前言、背景、一般原則、對(duì)全身毒性的建議和對(duì)給藥途徑的建議5個(gè)部分,并且分別描述了15種不同給藥途徑的藥品在改變劑型時(shí)應(yīng)增加的非臨床毒性研究?jī)?nèi)容。我國(guó)目前尚無(wú)這類(lèi)指導(dǎo)原則,了解該指導(dǎo)原則對(duì)我國(guó)完善相應(yīng)法規(guī)和制定相應(yīng)的指導(dǎo)原則及其對(duì)這類(lèi)藥物的審評(píng)有所啟迪,也對(duì)改變劑型類(lèi)藥物的開(kāi)發(fā)有所幫助,所以介紹該指導(dǎo)原則的主要內(nèi)容。

FDA issued “Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route Guidance” in October 2015, including introduction, background, general considerations, systemic toxicity consideration, route of administration considerations, and describing the additional nonclinical toxicity studies for reformulated drug products used in 15 different routes respectively. And there is no such guidance in our country at present. Because understanding the guidance for our country to improve the relevant regulations, to formulate corresponding guidance and to review these drug products are helpful, and for the development of these drug products also is helpful, therefore the main content is introduced.