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本文讨论了FDA关于外消旋体和纯立体异构体的批准受现行规章限制的观点。解释了批准一个纯对映异构体的申请所受规章限制的准则;批准一个外消旋体或一纯对映异构体,以及比较两者安全有效性而进行的临床研究申请所受规章限制的准则。
This article discusses the FDA’s view that the approval of racemates and pure stereoisomers is limited by current regulations. Explains the guidelines for regulatory approval of applications for a pure enantiomer; the approval of a racemate or a pure enantiomer, as well as a comparison of the safety and efficacy of both applications Limitation criteria.