Role of Stereoselective Assays in Bioequivalence Studies of Racemic Drugs: Have We Reached a Consensus?


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Abstract

The existence of stereoselectivity in metabolism and drug disposition, coupled with the existence of genetic polymorphisms and modulation of enantiomeric kinetics via special delivery systems, provides some compulsion to assess bioequivalence using stereoselective data. However, examination of the literature suggests that nonstereoselective data are commonly used for the bioequivalence assessment of drug racemates.

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