藥物非臨床安全性評(píng)價(jià)毒性試驗(yàn)有害作用的判斷非常重要，因其可為保護(hù)臨床試驗(yàn)暴露于新化學(xué)實(shí)體或藥物的受試者提供重要信息。毒性試驗(yàn)組織病理學(xué)檢查可提供受試物毒性作用的形態(tài)學(xué)數(shù)據(jù)，幫助分析和確定有害作用和非有害作用及其劑量水平。參照美國(guó)毒性病理學(xué)會(huì)（STP）和歐洲毒性病理學(xué)會(huì)（ESTP）的推薦最佳實(shí)踐或建議及其他相關(guān)文獻(xiàn)，對(duì)有害作用的定義、區(qū)分有害作用與非有害作用的要素、有害作用數(shù)據(jù)溝通和使用來(lái)評(píng)估人類潛在風(fēng)險(xiǎn)等建議等進(jìn)行簡(jiǎn)要概述分析，以期為我國(guó)非臨床藥物安全性評(píng)價(jià)毒性試驗(yàn)中有害作用判定提供參考。

The determination of adverse effects is crucial in the toxicity studies of nonclinical safety evaluation of drugs because it can provide important information for protecting the health of subjects exposed to new chemical or pharmaceutical entities during clinical trials. Histopathological examination can provide morphological data on the toxic effects of the test article to help the analysis and determination of adverse and non-adverse effects, as well as their dose levels. This paper briefly summarizes and analyzes the definition of adverse effects, discriminating key factors used to differentiate non-adverse effects from adverse effects, the recommendations for the communicating and use of adverse effect data in assessing potential human risk, which refers to the recommended best practices/suggestions of Society of Toxicologic Pathology (STP) and European Society of Toxicological Pathology (ESTP), and other relevant references, in order to provide some references for determining adverse effects in the toxicity studies during nonclinical safety evaluation of drugs in China.

江蘇省新藥一站式高效臨床前評(píng)價(jià)公共服務(wù)平臺(tái)建設(shè)項(xiàng)目（BM2021002）