在藥物非臨床安全性評價(jià)毒理學(xué)試驗(yàn)中，解剖病理學(xué)數(shù)據(jù)對受試物的后續(xù)臨床試驗(yàn)和使用至關(guān)重要。解剖病理學(xué)數(shù)據(jù)主觀性強(qiáng)，需要經(jīng)驗(yàn)豐富的專題病理學(xué)家對相關(guān)數(shù)據(jù)進(jìn)行綜合分析，才能進(jìn)行準(zhǔn)確的診斷和書寫合理的解剖病理學(xué)報(bào)告。而且需要專題負(fù)責(zé)人、專題監(jiān)察員、毒理學(xué)家和專題病理學(xué)家加強(qiáng)交流和合作來減少差錯(cuò)和控制風(fēng)險(xiǎn)。簡要介紹了解剖病理學(xué)數(shù)據(jù)差錯(cuò)原因和風(fēng)險(xiǎn)控制要點(diǎn)，以期為提高我國藥物非臨床安全性評價(jià)解剖病理學(xué)數(shù)據(jù)質(zhì)量和風(fēng)險(xiǎn)控制提供一定參考。

In routine toxicology studies for nonclinical safety evaluation of drugs, anatomic pathology data are critical for subsequent clinical trials and use of test articles. Anatomic pathology data are subjective and require an experienced toxicologic pathologist to comprehensively analyze the relevant data in order to make accurate diagnosis and write a reasonable anatomic pathology report. Furthermore, it is necessary for study directors, study monitors, toxicologists and toxicologic pathologists to strengthen communication and collaboration to minimize errors and control risks. The paper briefly introduces causes of errors and key points for risk control in anatomic pathology data, in order to provide some references for improving the quality of the anatomic pathology data and risk control in nonclinical safety evaluation of drugs in China.

R965.3

江蘇省新藥一站式高效非臨床評價(jià)公共服務(wù)平臺建設(shè)項(xiàng)目（BM2021002）