為提高療效和（或）降低單藥的某些不良反應，復方制劑作為藥品研發(fā)和評價中的常見類型成為關注的焦點。目前美國食品和藥物管理局（FDA）以及世界衛(wèi)生組織（WHO）均發(fā)布了復方制劑研發(fā)相關指南，分別對兩種或兩種以上晚期實體和早期實體組成的復方制劑非臨床及臨床階段研發(fā)進行了討論，對二者的相同以及不同點進行了詳細說明，旨在為注冊申請人研發(fā)該類型復方制劑提供參考。

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.