Drug development in inflammatory bowel disease: the role of the FDA.
Drug development in inflammatory bowel disease: the role of the FDA.
复制标题
炎症性肠病的药物开发：FDA 的作用。
DOI：
10.1002/ibd.21712
复制
发表时间：
2011
影响因子：
4.9
通讯作者：
Moss,AlanC
中科院分区：
文献类型：
--
作者：
Lahiff,Conor;Kane,Sunanda;Moss,AlanC
在美国销售的用于炎症性肠病（IBD）的所有药用化合物均由食品和药物管理局（FDA）通过可追溯至1906年的许多法规进行监管。FDA的主要当代作用是根据申办者提供的临床前和临床试验数据评估药物的安全性和有效性，以及随后的营销。这包括药代动力学、毒理学和临床研究以及批准后安全性监测。FDA通过大型随机对照试验（RCT）评估了美沙拉嗪制剂、布地奈德和生物疗法在IBD中的疗效和安全性。FDA用于批准IBD药物的终点以及批准新药物的机制已经发生了相当大的变化。本文综述了FDA批准药物的方法，用于批准IBD药物的基准，以及FDA在药物批准中的作用的近期争议。
All medicinal compounds sold in the United States for inflammatory bowel disease (IBD) are regulated by the Food and Drug Administration (FDA) via a number of regulations dating back to 1906. The primary contemporary role of the FDA is in the assessment of safety and efficacy, and subsequent marketing, of medications based on preclinical and clinical trial data provided by sponsors. This includes pharmacokinetic, toxicology and clinical studies, and postapproval safety monitoring. Mesalamine formulations, budesonide, and biologic therapies have all been assessed for efficacy and safety in IBD by the FDA via large randomized controlled trials (RCTs). There has been considerable evolution in the endpoints used by the FDA to approve medications for IBD, and the mechanisms through which newer agents have been approved. This review examines the methods of drug approval by the FDA, the bench-marks used to approve drugs for IBD, and recent controversies in the FDA's role in drug approval in general.