复方药物研发中临床药理学研究的一般考虑  

General considerations of clinical pharmacology research in fixed combination medicinal products

作　　者：韩鸿璨 刘冬 李娜 潘鹏玉 王骏 HAN Hong-can;LIU Dong;LI Na;PAN Peng-yu;WANG Jun(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2021年第24期3389-3391,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：固定剂量复方药物应用广泛。每种活性物质的吸收速度和程度是否和单药一致、各组分剂量组合的论证、组分间药物相互作用等,是复方药物开发过程中临床药理学的主要研究内容。需要开展的临床药理学研究根据是否含有新分子实体存在差异。本文通过案例阐述了复方药物研发中临床药理学研究的考虑。Fixed dose compound drugs are widely used. The absorption rate and degree of each compound, the dose of combination, drug interaction, etc. are the main contents of clinical pharmacology research. The clinical studies vary according to whether they contain new molecular entities. This paper gives an account of the consideration of clinical pharmacology in the research and development of compound drugs through some successful cases.

关 键 词：复方药物 食物影响 药物相互作用 生物利用度/生物等效性试验 

分 类 号：R95[医药卫生—药学]