ReviewClinical pharmacokinetics2016
Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics.
Review in Clinical pharmacokinetics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
57 citing papers in PubMed, 3 syntheses or guidelines pooled it.
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- Population pharmacokinetic models of anti-PD-1 mAbs in patients with multiple tumor types: A systematic review.Frontiers in immunology · 2022Pooled it
- Pharmacokinetics and Associated Efficacy of Emicizumab in Humans: A Systematic Review.Clinical pharmacokinetics · 2021Pooled it
- Sarilumab in Polyarticular-Course Juvenile Idiopathic Arthritis: Dose-Finding and 1-Year Analysis of a Phase 2b, Open-Label, Multicenter Study.Arthritis care & research · 2026Trial
- A Phase 1 Study of Ensitrelvir Fumaric Acid Tablets Evaluating the Safety, Pharmacokinetics and Food Effect in Healthy Adult Populations.Clinical drug investigation · 2023Trial
- Risk factors for anti-drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial.Journal of internal medicine · 2022Trial
- Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis.Rheumatology (Oxford, England) · 2021Trial
- Impact of Repeated Antigen Exposure on Humoral Tolerance: Antidrug Antibodies After Single-Dose Versus Multi-dose Adalimumab.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Article
- European Network on Optimizing Treatment With Therapeutic Antibodies in Chronic Inflammatory Diseases: Overview, Progress and Perspectives.Clinical and translational science · 2026Review
- Looking backward to move forward: a chemist's perspective on the future of radiopharmaceuticals.Journal of biological inorganic chemistry : JBIC : a publication of the Society of Biological Inorganic Chemistry · 2026Article
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- The Phenomenon of Anti-Drug Antibodies in Psoriasis: Mechanisms, Clinical Impact, and Therapeutic Strategies.International journal of molecular sciences · 2025Review
- Model-Informed Precision Dosing of Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria.Clinical pharmacokinetics · 2025Observational
- Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial.Pharmaceutics · 2025Review
- Sex-Related Differences in Immunotherapy Toxicities: Insights into Dimorphic Responses.Cancers · 2025Review
- Population pharmacokinetic analysis of bevacizumab in Japanese cancer patients with proteinuria: a prospective cohort study.Cancer chemotherapy and pharmacology · 2025Article
- Detection of antibodies to infliximab in routine care: a 4-year French retrospective study.Clinical and experimental immunology · 2025Article
- Population pharmacokinetics and exposure-response analyses of safety (ARIA-E and isolated ARIA-H) of lecanemab in subjects with early Alzheimer's disease.CPT: pharmacometrics & systems pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.