阿片類處方藥濫用在全球已成為嚴(yán)重的公共衛(wèi)生問題,防濫用阿片類制劑可不同程度地阻止其濫用.FDA為鼓勵(lì)、支持和加速研發(fā)可遏制濫用的阿片類產(chǎn)品,于2013年公布了"防濫用的阿片類藥物——評(píng)價(jià)和說明書"指導(dǎo)原則(草案).介紹該指導(dǎo)原則的主要內(nèi)容,包括上市前的實(shí)驗(yàn)室破壞和提取研究、藥動(dòng)學(xué)研究、臨床濫用可能性研究和上市后研究,希望對(duì)我國這方面的研究和審評(píng)有幫助.

Abuse of opioids has become a serious public health problem in the world, and abuse deterrence of opioids could prevent abuse to varying degrees. To encourage, support, and facilitate the research and development on abuse deterrence of opioids, FDA announced the "Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling (draft)" in 2013. This article introduces the main content of the guidance, including premarketing studies of laboratory manipulation and extraction studies, pharmacokinetic studies and clinical abuse potential studies as well as post-marketing studies. It is expected to be helpful for the research and review on this field in China.