TY - JOUR
T1 - Gender differences in drug bioequivalence
T2 - Time to rethink practices
AU - Koren, G.
AU - Nordeng, H.
AU - MacLeod, S.
PY - 2013/3
Y1 - 2013/3
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84874188816&partnerID=8YFLogxK
U2 - 10.1038/clpt.2012.233
DO - 10.1038/clpt.2012.233
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C2 - 23299647
AN - SCOPUS:84874188816
SN - 0009-9236
VL - 93
SP - 260
EP - 262
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
IS - 3
ER -