Implementation of toxicologic pathology peer review based on the new edition of China Good Laboratory Practice

VernacularTitle:基于新《药物非临床研究质量管理规范》的毒性病理同行评议
Author: Ji-Ye YIN ¹ ; He-Mei WANG ; Wen-Sheng QU ; Yan-Sheng DONG ; Quan-Jun WANG ; Xiao-Jing WU ; Si-Ming ZHANG ; Yong-Zhang TIAN
Author Information

1. 100850北京,北京毒物药物研究所,抗毒药物与毒理学国家重点实验室,国家北京药物安全评价研究中心
Keywords: Good Laboratory Practice(GLP); peer review; study pathologist; peer review pathologist
From: Journal of International Pharmaceutical Research 2017;44(12):1085-1088
CountryChina
Language:Chinese
Abstract: The Chinese Food and Drug Administration issued the new Good Laboratory Practice(GLP)for nonclinical safety studies in September 2017,which emphasizes the peer review during the pathology practice.Pathology peer review could verify and im?prove the accuracy and quality of pathology diagnoses and interpretations in discussion.Pathology peer review is recommended when important risk assessment or business decisions are based on nonclinical studies.The objectives of this review are to provide a unified interpretation of the new regulation and recommend compliant processes for organizations to implement.