Haley Patrick J
Global Safety Assessment, AstraZeneca Pharmaceuticals, Wilmington, Delaware 19850, USA.
J Immunotoxicol. 2005 Oct 1;2(4):181-3. doi: 10.1080/15476910500362697.
Recently finalized regulatory guidance documents concerned with the identification of immunotoxicity (CPMP: Note for Guidance on Repeated Dose Toxicity; FDA: Guidance for Industry, Immunotoxicology Evaluation of Investigational New Drugs; ICH S8) state that immunotoxicity testing should be performed on all new investigational drugs or medicinal products. In addition, all documents clearly identify gross and microscopic examination of lymphoid tissues as necessary and pivotal first steps in the assessment of new xenobiotics for immunotoxic potential. However, as is true for the evaluation of other organs systems, there are numerous approaches to the histopathologic examination of lymphoid tissues. To assist in a more uniform and consistent histopathologic assessment of the immune system, the Society of Toxicologic Pathology (STP), has recently prepared "best practice" recommendations concerning the collection, interpretation and reporting of organ weights, gross and microscopic observations, and other pathology data relevant to the immune system. The STP recommendations are intended to provide a scientifically sound and well-considered guidance document for routine pathology evaluation of the immune system. This presentation will consider the implications of this "best practice" document and place these recommendations in the context of normal animal tissue variability.
最近定稿的有关免疫毒性鉴定的监管指导文件（欧洲药品评价局：重复给药毒性指导说明；美国食品药品监督管理局：新药研究免疫毒理学评价行业指南；国际人用药品注册技术协调会S8）指出，应对所有新的研究性药物或医药产品进行免疫毒性测试。此外，所有文件均明确将淋巴组织的大体和显微镜检查确定为评估新的外源性物质免疫毒性潜力时必要且关键的首要步骤。然而，与其他器官系统的评估一样，淋巴组织的组织病理学检查有多种方法。为了协助对免疫系统进行更统一和一致的组织病理学评估，毒理病理学会（STP）最近编写了关于器官重量、大体和显微镜观察以及与免疫系统相关的其他病理数据的收集、解释和报告的“最佳实践”建议。STP的建议旨在为免疫系统的常规病理学评估提供一份科学合理且经过充分考虑的指导文件。本报告将探讨这份“最佳实践”文件的影响，并将这些建议置于正常动物组织变异性的背景下进行考量。
