毒性病理學是一門綜合了病理學和毒理學兩門學科的交叉學科，主要研究有毒物質的潛在作用。準確診斷病變和報告組織病理學檢查結果將繼續(xù)在藥物非臨床安全性評價中發(fā)揮關鍵作用。此外，毒性病理學評價必須結合其他相關數(shù)據(jù)進行，例如臨床觀察、體質量變化、臨床病理學結果、以及代謝和藥動學數(shù)據(jù)。簡要介紹了組織病理學檢查的基本要素、組織病理學的特點、組織病理學診斷注意事項、病理學數(shù)據(jù)分析和報告病理學結果的要點，以期為中國藥物非臨床安全性評價毒性病理學組織病理學檢查及病理學數(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平臺建設項目（BM2021002）