title: Gender differences in drug bioequivalence: time to rethink practices.
abstract: 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.
authors.affiliation: Motherisk Program, Division of Clinical Pharmacology/Toxicology, SickKids Hospital, University of Toronto, Toronto, Ontario, Canada. gidiup_2000@yahoo.com
authors.forename: G
authors.initials: G
authors.lastname: Koren
authors.forename: H
authors.initials: H
authors.lastname: Nordeng
authors.forename: S
authors.initials: S
authors.lastname: MacLeod
mesh_terms: D019540:Area Under Curve; D005260:Female; D006801:Humans; D008297:Male; D012727:Sex Characteristics; D013810:Therapeutic Equivalency