药物复方制剂研发指南探讨

Discussion on guidance for reseach and development of compound drug

为提高疗效和(或)降低单药的某些不良反应,复方制剂作为药品研发和评价中的常见类型成为关注的焦点。目前美国食品和药物管理局(FDA)以及世界卫生组织(WHO)均发布了复方制剂研发相关指南,分别对两种或两种以上晚期实体和早期实体组成的复方制剂非临床及临床阶段研发进行了讨论,对二者的相同以及不同点进行了详细说明,旨在为注册申请人研发该类型复方制剂提供参考。

To improve the efficacy and/or reduce certain adverse reactions, the development and evaluation for compound drugs focus on the combination which provides the significant therapeutic advantages. Recently, both the US Food and Drug Administration （FDA） and World Health Organization （WHO） published the related Guidance for Developing Drug Combination. The article describes the development of the combinations used for two or more late stage entities and early stage entities in nonclinical and clinical stages and illustrates the same and different aspects in detail, so as to provide the reference for the sponsors in the reseach and development of drug combination.