病理學(xué)同行評議在藥物非臨床安全性評價毒性病理學(xué)檢查中具有重要地位，同行評議可以確定診斷術(shù)語的準(zhǔn)確性和一致性、確定完整性、確定病理學(xué)報告內(nèi)容的正確性，并可提高藥物非臨床毒理學(xué)研究的質(zhì)量。2021年12月，美國食品藥品監(jiān)督管理局（FDA）頒布了《非臨床毒理學(xué)研究病理學(xué)同行評議問答行業(yè)指南》。美國毒性病理學(xué)會（STP）科學(xué)和監(jiān)管政策委員會（SRPC）工作組對FDA指南進行了深入分析和審閱，提供了評論和解釋，并將多個國家和地區(qū)的毒性病理學(xué)會和美國質(zhì)量保證學(xué)會（SQA）審閱該指南后，關(guān)于如何在遵循良好實驗室規(guī)范（GLP）的非臨床毒理學(xué)研究中管理、開展和記錄病理學(xué)同行評議的建議進行了匯總。簡要闡述STP的SRPC工作組對FDA《非臨床毒理學(xué)研究病理學(xué)同行評議問答行業(yè)指南》9個問答的評論和建議，以期為我國藥物非臨床安全性評價機構(gòu)更好地開展遵循GLP的病理學(xué)同行評議提供一定參考。

Pathology peer review holds significant importance in toxicologic pathology examination during nonclinical safety evaluation of drugs. Peer review is essential to determine accuracy and consistency of diagnostic nomenclature, determine completeness, and determine the correctness of textual interpretations of pathology report, thereby improving the quality of nonclinical toxicology studies of drugs. In december 2021, the United States Food and Drug Administration (FDA) issued the guidance for industry titled pathology peer review in nonclinical toxicology studies: Questions and answers. A working group commissioned by the Scientific and Regulatory Policy Committee (SRPC) of Society of Toxicologic Pathology (STP) conducted an in-depth review and analysis of the guidance, provided comment and interpretation, and summarized recommendations from many toxicologic pathology societies from different countries and regions as well as Society of Quality Assurance (SQA) on how to manage, conduct and document pathology peer review in nonclinical toxicology studies complied with Good Laboratory Practice (GLP) regulations. The comments and suggestions on all nine Q&A items in the FDA guidance by the working group of the STP were briefly reviewed, with a purpose to provide some references for facilities for nonclinical safety evaluation of drugs in China to better conduct pathology peer review complied with GLP regulations.

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2023年國家發(fā)改委基于AI的創(chuàng)新藥物研發(fā)服務(wù)平臺項目