藥物安全性評(píng)價(jià)中毒性病理學(xué)評(píng)價(jià)是最重要的一個(gè)步驟，而毒性病理學(xué)評(píng)價(jià)作為藥物安全性評(píng)價(jià)體系中重要的一環(huán)，用以確定損傷靶器官、靶組織的形態(tài)及程度變化，評(píng)價(jià)受試藥物是否具有毒性并判斷其能否推向臨床的重要指標(biāo)。對(duì)組織學(xué)技術(shù)進(jìn)行質(zhì)量控制與評(píng)估則是確保毒性病理診斷準(zhǔn)確性及一致性的重要前提。該文對(duì)組織學(xué)技術(shù)流程進(jìn)行敘述并探討流程中相關(guān)影響因素。

The evaluation of toxicological pathology is the most important step in the evaluation of drug safety, which is an important part of system in drug safety evaluation. It is used to identify the changes in morphology and degree of target organs and target tissues, to evaluate whether the drugs are toxic and judge they can be enter the clinic or not. The quality control and evaluation of histological techniques is an important prerequisite to ensure the accuracy and consistency of the diagnosis of toxicological pathology. This paper describes the process of histological techniques and discusses the related factors in the process.

國家科技重大新藥創(chuàng)制項(xiàng)目（2015ZX09501004）；天津市科技計(jì)劃項(xiàng)目（16PTGCCX00090）