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Review
. 2016 Jul;55(7):789-805.
doi: 10.1007/s40262-015-0361-4.

Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics

Katherine L Gill  1 , Krishna K Machavaram  1 , Rachel H Rose  1 , Manoranjenni Chetty  2
Affiliations
Review

Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics

Katherine L Gill et al. Clin Pharmacokinet. 2016 Jul.

Abstract

Understanding inter-subject variability in drug pharmacokinetics and pharmacodynamics is important to ensure that all patients attain suitable drug exposure to achieve efficacy and avoid toxicity. Inter-subject variability in the pharmacokinetics of therapeutic monoclonal antibodies (mAbs) is generally moderate to high; however, the factors responsible for the high inter-subject variability have not been comprehensively reviewed. In this review, the extent of inter-subject variability for mAb pharmacokinetics is presented and potential factors contributing to this variability are explored and summarised. Disease status, age, sex, ethnicity, body size, genetic polymorphisms, concomitant medication, co-morbidities, immune status and multiple other patient-specific details have been considered. The inter-subject variability for mAb pharmacokinetics most likely depends on the complex interplay of multiple factors. However, studies aimed at investigating the reasons for the inter-subject variability are sparse. Population pharmacokinetic models and physiologically based pharmacokinetic models are useful tools to identify important covariates, aiding in the understanding of factors contributing to inter-subject variability. Further understanding of inter-subject variability in pharmacokinetics should aid in development of dosing regimens that are more appropriate.

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