FDA抗癌药物非临床评价指导原则_英文_.pdfVIP

- 236 - Drug Evaluation Research 第 34 卷 第 3 期 2011 年 6 月 •国外信息专栏• FDA 抗癌药物非临床评价指导原则 编者按：2010 年3 月5 日，美国FDA 发布了“抗癌药物非临床评价指导原则（Guidance for Industry S9 Nonclinical Evaluation for Anticancer Pharmaceuticals ）”，为抗癌药物研发过程中开展合理的非临床研究设计提供信息，并提供了科学的参考依据以 支持抗癌药物在临床试验阶段的发展，达到治疗病人、减轻非必要不良反应的目的。同时，减少不必要的动物使用，来降低、 优化或替代相关的资源使用。 该指导原则主要包括以下内容： 1) 抗癌药物非临床评价的范围和一般原则。 2) 支持非临床评价所需开展的研究项目。 3) 支持临床试验设计和药品上市所需的非临床评价数据。 4) 其他需考虑的事项，如药物代谢产物和杂质的评价。 现节录其支持非临床评价所需开展的研究项目部分刊载如下，为国内从事抗癌药物研发的相关企业提供可借鉴的内容。 Guidance for Industry S9 Nonclinical Evaluation for Anticancer Pharmaceuticals This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. II. STUDIES TO SUPPORT NONCLINICAL vital organ functions (including cardiovascular, EVALUATION (2) respiratory, and central nervous systems) should be A. Pharmacology (2.1) available before the initiation of clinical studies; such Prior to Phase 1 studies, preliminary charac- parameters could be included in general toxicology terization of the mechanism(s) of action and schedule studies. Detailed clinical observations following dependencies, as well as anti-tumor activity of the dosing and appropriate electrocardio