Toxicologic pathology is the science that integrates the disciplines of pathology and toxicology and is concerned about the effects of potentially noxious substances. The histopathology evaluation in the toxicology study has developed a standard technical procedure through long-term practice of toxicologic pathologists, which plays an important role in the identification of drug risk. This paper briefly introduced the internationally recognized fundamental elements in the nonclinical safety evaluation of drugs, such as the pathologist's qualification and responsibilities, the data and information obtained by the pathologist before microscopic examination, the general procedure of toxicologic pathology evaluation, several factors affecting accuracy and consistency of toxicologic pathology evaluation, etc. At the same time, to complete toxicologic histopathology evaluation in nonclinical toxicology studies in accordance with standard technical procedures could reduce the pathology diagnostic bias, and ultimately get high-quality pathology report and provide high-value data and information for pathologists, toxicologists and reviewers in regulators.
Qu Zhe, Lv Jianjun, Lin Zhi, Huo Guitao, Yang Yanwei, Zhang Di, Zhang Shuo, HuoYan, Wang Xue, Li Bo
. A Brief Introduction of Fundamental Elements of the Toxicologic Pathology Evaluation in the Nonclinical Safety Evaluation of Drugs[J]. Chinese Pharmaceutical Affairs, 2017
, 31(5)
: 472
-478
.
DOI: 10.16153/j.1002-7777.2017.05.003
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