在藥物非臨床安全性評價毒理學試驗中，解剖病理學數(shù)據(jù)對受試物的后續(xù)臨床試驗和使用至關重要。解剖病理學數(shù)據(jù)主觀性強，需要經(jīng)驗豐富的專題病理學家對相關數(shù)據(jù)進行綜合分析，才能進行準確的診斷和書寫合理的解剖病理學報告。而且需要專題負責人、專題監(jiān)察員、毒理學家和專題病理學家加強交流和合作來減少差錯和控制風險。簡要介紹了解剖病理學數(shù)據(jù)差錯原因和風險控制要點，以期為提高我國藥物非臨床安全性評價解剖病理學數(shù)據(jù)質量和風險控制提供一定參考。

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公共服務平臺建設項目（BM2021002）