医学
哮喘
慢性阻塞性肺病
重症监护医学
吸入性皮质类固醇
药品
哮喘管理
作者
Marianne Mann,Robert J. Meyer
出处
期刊:Respiratory Care
[Daedalus Enterprises]
日期:2018-05-24
卷期号:63 (6): 797-817
被引量:4
标识
DOI:10.4187/respcare.06009
摘要
This review addresses drug development intended to support United States clearance for asthma and COPD by explaining basic regulatory terms and broadly discussing the regulatory pathways to clearance. Some of the key clinical regulatory challenges that are faced by drugs for asthma and COPD are explained and clarified, both overall and by class of drug, citing relevant examples that emphasize key lessons. Generic drug development of inhaled drugs is also addressed. The purpose of this review is to provide the reader with a greater understanding and appreciation of asthma and COPD drug development from the regulatory perspective.
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