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Cited by 82Monoclonal and Polyclonal Antibodies ResearchBiosimilars and Bioanalytical MethodsPharmaceutical studies and practices

The DOI matches its Crossref record; 211 of the 211 references it cites were found in a registry or an index.

Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics

Gill, Katherine L., Machavaram, Krishna K., Rose, Rachel H., Chetty, Manoranjenni·2016·Clinical Pharmacokinetics
DOI 10.1007/s40262-015-0361-4
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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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Crossref · 10.1007/s40262-015-0361-4

Cites

211 of 211 references verified0 citation errors · 0 not checkable

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Citations

Cites

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Research works printed but not linked: 3

  1. Lentner C. Geigy scientific tables, vol. 1: units of measurement, body fluids, composition of the body, and nutrition. 8th ed. Basel: Wiley; 1981. pp. 217–27.
  2. Kauffman R. Drug therapeutics in the infant and child. In: Yaffe S, Aranda J, editors. Pediatric pharmacology: therapeutic principles in practise. Philadelphia: WB Saunders; 1992. p. 212–9.
  3. Freeman T. Gamma globulin metabolism in normal humans and in patients. Ser Haematol. 1965;4:76–86.

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Metadata

Authors
Gill, K. L., Machavaram, K. K., Rose, R. H., & Chetty, M.
Affiliations
Simcyp (United Kingdom) (GB)
Corresponding author
Chetty, Manoranjenni
ORCID
Venue
Clinical Pharmacokinetics
Publisher
Springer Science and Business Media LLC
Published
2016-01-27
Volume
55
Issue
7
Pages
789-805
ISSN
  • 0312-5963 (ISSN-L)
  • 1179-1926
DOI
10.1007/s40262-015-0361-4
OpenAlex
W2296252503
Cited by
82
References
210
Citations by year
2026: 3 · 2025: 12 · 2024: 9 · 2023: 11 · 2022: 11 · 2021: 7 · 2020: 5 · 2019: 6 · 2018: 10 · 2017: 7 · 2016: 1
FWCI
1.24
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • Clinical Pharmacokinetics (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
  • Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords
monoclonal antibodies, interindividual variability, pharmacokinetics, covariates, genetic polymorphism, population pharmacokinetic model, physiologically based pharmacokinetic modeling, dosing regimen, disease status, immune status, concomitant medications, comorbidities
MeSH terms
Age Factors, Antibodies, Monoclonal, Body Weights and Measures, Dose-Response Relationship, Drug, Drug Interactions, Ethnicity, Humans, Lymphatic System, Models, Biological, Polymorphism, Genetic, Receptors, Fc, Severity of Illness Index, Sex Factors, Histocompatibility Antigens Class I, Comorbidity

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