Medicines For Women

Aim To evaluate the combined effect of sex-and age-related physiological and biological changes on drug pharmacokinetics. Findings Median peak concentration and drug exposure were on average 22% and 20% higher in women compared with men. With increasing age, sex differences in peak concentration tended to be more pronounced but remained similar for drug exposure. Message The pharmacokinetic differences between women and men are modest and, with the exception of peak concentration, remain constant with increasing age.

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Understanding Inter-Individual Variability in Monoclonal Antibody Disposition

Thomas

Balthasar

2019

Antibodies

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Monoclonal antibodies (mAbs) are currently the largest and most dominant class of therapeutic proteins. Inter-individual variability has been observed for several mAbs; however, an understanding of the underlying mechanisms and factors contributing to inter-subject differences in mAb disposition is still lacking. In this review, we analyze the mechanisms of antibody disposition and the putative mechanistic determinants of inter-individual variability. Results from in vitro, preclinical, and clinical studies were reviewed evaluate the role of the neonatal Fc receptor and Fc gamma receptors (expression and polymorphism), target properties (expression, shedding, turnover, internalization, heterogeneity, polymorphism), and the influence of anti-drug antibodies. Particular attention is given to the influence of co-administered drugs and disease, and to the physiological relevance of covariates identified by population pharmacokinetic modeling, as determinants of variability in mAb pharmacokinetics.

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Medicines For Women

Cited by 5 publications

References 755 publications

Drug Trials Snapshots and Sexless Drug Labels—Reply

Drug Trials Snapshots and Sexless Drug Labels—Reply

Sex-related pharmacokinetic differences with aging

Understanding Inter-Individual Variability in Monoclonal Antibody Disposition

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