Premium
Role of Stereoselective Assays in Bioequivalence Studies of Racemic Drugs: Have We Reached a Consensus?
Author(s) -
Srinivas Nuggehally R.
Publication year - 2004
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270003262098
Subject(s) - bioequivalence , stereoselectivity , enantiomer , pharmacology , drug , pharmacokinetics , disposition , chemistry , computational biology , stereochemistry , medicine , biology , psychology , biochemistry , social psychology , catalysis
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.