ABSTRACT
The importance of stereochemistry in drug action is gaining greater attention in medical practice, and a basic knowledge of the subject will be necessary for clinicians to make informed decisions regarding the use of single-enantiomer drugs. The biological activity of chiral substances often depends upon their stereochemistry, since the living body is a highly chiral environment. Absorption, distribution, metabolism and elimination of drugs from the body also involves with their interactions with various proteins. Food and Drug Administration invites discussion with sponsors concerning whether to pursue development of the racemate or the individual enantiomer. All information developed by the sponsor or available from the literature that is relevant to the chemistry, pharmacology, toxicology, or clinical actions of the stereoisomers should be included in the IND and NDA submissions. The chemistry section of the application should contain the requisite information to assure the identity, quality, purity and strength of the drug substance.
