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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。
In order to improve the curative effect and / or to reduce certain adverse reactions of the single drug, the compound preparation becomes the focus of attention as a common type in drug development and evaluation. At present, the United States Food and Drug Administration (FDA) and the World Health Organization (WHO) have released guidelines on the development of compound preparations for the non-clinical and clinical research and development of two or more advanced entities and early entities respectively The discussion of the same and differences between the two carried out a detailed description of the purpose of registering applicants to develop this type of compound preparation for reference.