The FDA perspective on the development of stereoisomers
作者:
Wilson H. De Camp,
期刊:
Chirality
(WILEY Available online 1989)
卷期:
Volume 1,
issue 1
页码: 2-6
ISSN:0899-0042
年代: 1989
DOI:10.1002/chir.530010103
出版商: Alan R. Liss, Inc.
关键词: optical isomers;stereochemistry;enantiomers;Food and Drug Administration;drug development;drug regulation
数据来源: WILEY
摘要:
AbstractThe current regulatory position of the Food and Drug Administration is discussed with regard to the approval of racemates and pure stereoisomers. Circumstances in which stereochemically sensitive analytical methods are necessay to ensure the safety and efficacy of a drug are described. Regulatory guidelines are interpreted for applications for the approval of a pure enantiomer in which the racemate is marketed, for the approval of eitehr a racemate or a pure enantiomer in which neither is marketed, and for clinical investigations to compare the safety and efficacy of a racemate and its enantiomers. Examples of te basis for such regulation are drawn from historical situations (thalidomide, benoxaprofen) as well as currently marketed drugs (arylproionic acids, disopyramide, indacrinone).
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