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Gender Differences in Drug Bioequivalence: Time to Rethink Practices
Author(s) -
Koren G,
Nordeng H,
MacLeod S
Publication year - 2013
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.233
Subject(s) - bioequivalence , drug , medicine , pharmacology , pharmacokinetics
Currently, bioequivalence (BE) studies are carried out exclusively in males, assuming that intrasubject variabilities are similar between the sexes. This article challenges this hypothesis on the basis of available evidence and urges that studies of BE of sufficient power be undertaken in women also for all generic drugs aimed at women. Clinical Pharmacology & Therapeutics (2013); 93 3, 260–262. doi: 10.1038/clpt.2012.233