毒性病理學(xué)是從形態(tài)學(xué)的角度闡明藥物毒性造成的組織損傷,包括藥物損傷類型、作用部位、病變程度和預(yù)后等基本問題,為臨床前藥物安全性評(píng)價(jià)研究提供客觀準(zhǔn)確的數(shù)據(jù)支持。因此,毒性病理學(xué)在藥物安全性評(píng)價(jià)中具有重要作用,其數(shù)據(jù)或結(jié)論常常決定了許多藥物研發(fā)項(xiàng)目的終止或繼續(xù)。從毒性病理學(xué)的特點(diǎn)、規(guī)范性管理、病理學(xué)新技術(shù)的發(fā)展（包括原位雜交、激光掃描細(xì)胞技術(shù)、激光捕獲顯微切割等）,以及毒性病理學(xué)發(fā)展面臨的問題等方面進(jìn)行了簡(jiǎn)要論述。

Toxicological pathology is a morphological elucidatet ion of tissue damage caused by drug toxicity, including damage type, location, severity grade and prognosis. It provides objective and accurate data to support preclinical drug safety evaluation. Therefore, toxicological pathology plays an important role in drug safety evaluation, and the pathologic data or conclusion often determines the termination or continuation in many drug development projects. In this paper, the characteristic of toxicological pathology, standardized management, the development of new techniques including in situ hybridization, laser scanning cytometry and laser capture microdissection, and related problems in pathology are discussed briefly.

國(guó)家科技重大專項(xiàng)（2015ZX09501007-004）；重大新藥創(chuàng)制（2015ZX09501004-002）