為提高療效和（或）降低單藥的某些不良反應(yīng)，復(fù)方制劑作為藥品研發(fā)和評(píng)價(jià)中的常見(jiàn)類型成為關(guān)注的焦點(diǎn)。目前美國(guó)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(fù)方制劑研發(fā)相關(guān)指南，分別對(duì)兩種或兩種以上晚期實(shí)體和早期實(shí)體組成的復(fù)方制劑非臨床及臨床階段研發(fā)進(jìn)行了討論，對(duì)二者的相同以及不同點(diǎn)進(jìn)行了詳細(xì)說(shuō)明，旨在為注冊(cè)申請(qǐng)人研發(fā)該類型復(fù)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.