TY - JOUR
T1 - Sex dependent pharmacokinetics and bioequivalence - Time for change
AU - Koren, Gideon
PY - 2013/11/6
Y1 - 2013/11/6
N2 - Bioequivalence studies have historically been performed largely in young males and then extrapolated to be applicable to both sexes at any age. This tendency continues today, yet a number of studies have shown that drug pharmacokinetics can be significantly different in women than in men, even as regards intra-patient variability. Some of our assumptions when treating women may not be accurate if we base our decisions on information obtained from studies conducted in men. Furthermore, women can have various physiological states that can affect drug disposition, and one of the most significant is pregnancy.
AB - Bioequivalence studies have historically been performed largely in young males and then extrapolated to be applicable to both sexes at any age. This tendency continues today, yet a number of studies have shown that drug pharmacokinetics can be significantly different in women than in men, even as regards intra-patient variability. Some of our assumptions when treating women may not be accurate if we base our decisions on information obtained from studies conducted in men. Furthermore, women can have various physiological states that can affect drug disposition, and one of the most significant is pregnancy.
KW - Absorption
KW - Adverse drug reactions
KW - Bioequivalence
KW - Intra-subject variability
KW - Pharmacokinetics
KW - Pregnancy
UR - https://www.scopus.com/pages/publications/84887386070
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C2 - 24214491
AN - SCOPUS:84887386070
SN - 1710-6222
VL - 20
SP - e358-e361
JO - Journal of Population Therapeutics and Clinical Pharmacology
JF - Journal of Population Therapeutics and Clinical Pharmacology
IS - 3
ER -