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Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics.
- Source :
-
Clinical Pharmacokinetics . Jul2016, Vol. 55 Issue 7, p789-805. 17p. - Publication Year :
- 2016
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *THERAPEUTIC use of monoclonal antibodies
*PHARMACODYNAMICS
*PHARMACOKINETICS
*DRUG toxicity
*COMORBIDITY
*GENETIC polymorphisms
*DRUG dosage
*AGE distribution
*ANTHROPOMETRY
*BIOLOGICAL models
*CELL receptors
*DRUG interactions
*DOSE-effect relationship in pharmacology
*ETHNIC groups
*HISTOCOMPATIBILITY antigens
*LYMPHATICS
*MONOCLONAL antibodies
*SEX distribution
*SYSTEMATIC reviews
*SEVERITY of illness index
Subjects
Details
- Language :
- English
- ISSN :
- 03125963
- Volume :
- 55
- Issue :
- 7
- Database :
- Academic Search Index
- Journal :
- Clinical Pharmacokinetics
- Publication Type :
- Academic Journal
- Accession number :
- 117355047
- Full Text :
- https://doi.org/10.1007/s40262-015-0361-4