Objective: To elaborate the importance and key points of quality control for anatomical pathology of toxicological studies, so as to provide references for improving the quality control for anatomical pathology in facilities for nonclinical safety evaluation of drugs in China. Methods: The organization and management, Standard Operating Procedures (SOPs), anatomical pathology examination, pathology report preparation, and the key points of quality control in histopathology examination of the pathology division in facilities for nonclinical safety evaluation of drugs are reviewed one by one. Results: Quality control for anatomical pathology of toxicological studies could ensure the authenticity, accuracy, completeness and reliability of pathological data, and provide reliable data support for determining the target organs, adverse effects and mechanism of action of the test articles. Conclusion: Toxicological pathology is an important part of the toxicological studies in facilities for nonclinical safety evaluation of drugs. The quality control for anatomical pathology in toxicological studies is very important and should be given high priority.
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