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重复给药毒性和致癌性研究中组织病理学检查的推荐组织清单:毒理病理学会(STP)的提议

Recommended tissue list for histopathologic examination in repeat-dose toxicity and carcinogenicity studies: a proposal of the Society of Toxicologic Pathology (STP).

作者信息

Bregman Carla L, Adler Rick R, Morton Daniel G, Regan Karen S, Yano Barry L

机构信息

Bristol-Myers Squibb Company, Syracuse, New York, USA.

出版信息

Toxicol Pathol. 2003 Mar-Apr;31(2):252-3. doi: 10.1080/01926230390183751.

Abstract

The Executive Committee of the Society of Toxicologic Pathology (STP) appointed an ad hoc task force to devise and recommend a standard list of tissues to be evaluated histopathologically in repeat-dose toxicity and carcinogenicity studies that are used to support the registration of new pharmaceutical products. The recommended tissue list is intended to be a minimum core list that can be used for all types of repeat-dose toxicity and carcinogenicity studies, regardless of route of administration, species or strain of mammalian laboratory animal, duration, or class of drug to be tested. The resulting recommendations of the task force, presented here, were subsequently reviewed by the STP membership and endorsed by the STP Executive Committee.

摘要

毒理病理学会(STP)执行委员会任命了一个特别工作组,以制定并推荐一份标准组织清单,用于在支持新药品注册的重复给药毒性和致癌性研究中进行组织病理学评估。推荐的组织清单旨在作为一个最低核心清单,可用于所有类型的重复给药毒性和致癌性研究,无论给药途径、哺乳动物实验动物的物种或品系、持续时间或待测试药物的类别如何。特别工作组的最终建议在此呈现,随后经STP成员审核并获STP执行委员会认可。

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