毒性病理學(xué)是一門綜合了病理學(xué)和毒理學(xué)兩門學(xué)科的交叉學(xué)科，主要研究有毒物質(zhì)的潛在作用。準(zhǔn)確診斷病變和報告組織病理學(xué)檢查結(jié)果將繼續(xù)在藥物非臨床安全性評價中發(fā)揮關(guān)鍵作用。此外，毒性病理學(xué)評價必須結(jié)合其他相關(guān)數(shù)據(jù)進(jìn)行，例如臨床觀察、體質(zhì)量變化、臨床病理學(xué)結(jié)果、以及代謝和藥動學(xué)數(shù)據(jù)。簡要介紹了組織病理學(xué)檢查的基本要素、組織病理學(xué)的特點(diǎn)、組織病理學(xué)診斷注意事項(xiàng)、病理學(xué)數(shù)據(jù)分析和報告病理學(xué)結(jié)果的要點(diǎn)，以期為中國藥物非臨床安全性評價毒性病理學(xué)組織病理學(xué)檢查及病理學(xué)數(shù)據(jù)分析提供一定參考。

Toxicologic pathology is the science that integrates the disciplines of pathology and toxicology and is concerned with the effects of potentially noxious substances. Accurate diagnosis and reporting of findings derived from histopathological examination have been and will continue to play a critical role in the nonclinical safety evaluation of drugs. In addition, the toxicologic pathology assessment must integrate other relevant data, such as clinical signs, body weight changes, clinical pathology findings, as well as metabolism and pharmacokinetic data. The paper gave a brief introduction of the fundamental elements of histopathological examination, features of the histopathology, considerations of diagnosis of histopathology, analysis of pathology data and reporting pathology findings, in order to provide some references for toxicologic pathology assessment and pathological data analysis during preclinical safety evaluation of drugs in China.

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