臨床前藥物安全評價(jià)毒性病理學(xué)靶器官毒性的檢查和評價(jià)要結(jié)合大體病理學(xué)、組織病理學(xué)及臨床病理學(xué)檢查結(jié)果進(jìn)行全面考慮、逐步分析，并使用國際統(tǒng)一推薦的診斷術(shù)語及診斷標(biāo)準(zhǔn)，避免主觀、不確切的診斷。簡要介紹了臨床前藥物安全評價(jià)毒性病理學(xué)靶器官毒性檢查的基本原則，大體病理學(xué)檢查，組織病理學(xué)檢查，毒性病理學(xué)診斷方法、程序及注意事項(xiàng)，診斷術(shù)語及診斷標(biāo)準(zhǔn)的國際統(tǒng)一，臨床病理學(xué)參數(shù)分析，解剖病理學(xué)與臨床病理學(xué)數(shù)據(jù)結(jié)合一致性分析等內(nèi)容，以期為我國臨床前藥物安全評價(jià)毒性病理學(xué)靶器官毒性檢查及評價(jià)提供一定參考。

Examination and assessment of target organ toxicity in toxicologic pathology of preclinical safety evaluation of drugs should combine the results of the gross pathology, histopathology and clinical pathology examination data in a well-considered, stepwise approach. In addition, the nomenclature and diagnostic criteria recommended by INHAND should be used to avoid subjective and inappropriate diagnosis. In this paper, we briefly introduced the basic principles for the examination of organ toxicity in toxicology studies, gross pathology, histopathology, diagnostic approach, procedures, and considerations, international harmonization of diagnostic term and criteria, clinical pathology parameters analysis, results of a well-concerted combination of anatomical and clinical pathology data so as to provide some reference for the examination and assessment of target organ toxicity in toxicologic pathology in the field of preclinical safety evaluation of drugs in China.

“十二五”國家科技重大專項(xiàng)課題（2015ZX09501004-002，2015ZX09501007-004）