The FDA perspective on the development of stereoisomers.

摘要: The current regulatory position of the Food and Drug Administration is discussed with regard to approval racemates pure stereoisomers. Circumstances in which stereochemically sensitive analytical methods are necessay ensure safety efficacy a drug described. Regulatory guidelines interpreted for applications enantiomer racemate marketed, eitehr or neither clinical investigations compare its enantiomers. Examples te basis such regulation drawn from historical situations (thalidomide, benoxaprofen) as well currently marketed drugs (arylproionic acids, disopyramide, indacrinone).