ArticlePharmaceutical research2015
Across-Species Scaling of Monoclonal Antibody Pharmacokinetics Using a Minimal PBPK Model.
Article in Pharmaceutical research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 4 of them syntheses that pooled it.
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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.
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Who cites it
46 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Metronidazole Pharmacokinetics Across Species: Meta-Analysis Integrating Allometric Scaling and Minimal Physiologically-Based Pharmacokinetic Modeling.The AAPS journal · 2025Pooled it
- Across-species meta-analysis of dexamethasone pharmacokinetics utilizing allometric and scaling modeling approaches.Biopharmaceutics & drug disposition · 2021Pooled it
- Pre-Clinical Testing of Therapies for Traumatic Brain Injury.Journal of neurotrauma · 2018Guideline
- Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model Verification.Drug metabolism and disposition: the biological fate of chemicals · 2015Pooled it
- Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients.Clinical pharmacology and therapeutics · 2026Trial
- Non-Clinical Evaluation of the Anti-PD-1 Antibody UDIZ-007.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Article
- Quantitative Investigation of ATP Switch Concept of STA551 Through Combined In Vivo Tissue Distribution Studies and Physiologically Based Pharmacokinetic Modeling.The AAPS journal · 2026Article
- Multi-species assessment of propranolol pharmacokinetics via minimal and whole-body PBPK modeling.Frontiers in pharmacology · 2026Article
- Review
- Physiologically Based Pharmacokinetic Model for Prediction of Immunoglobulins Exposure in Pregnant Women.Antibodies (Basel, Switzerland) · 2025Article
- Cross-Species Extrapolation of Neonatal Fc Receptor (FcRn) Binding Affinity to Predict Monoclonal Antibody Pharmacokinetics in Humans Using Physiologically Based Pharmacokinetic Modeling (PBPK): Are We There Yet?ACS pharmacology & translational science · 2025Article
- Formulation Strategy of BCS-II Drugs by Coupling Mechanistic In-Vitro and Nonclinical In-Vivo Data with PBPK: Fundamentals of Absorption-Dissolution to Parameterization of Modelling and Simulation.AAPS PharmSciTech · 2025Review
- Refined target-mediated drug disposition modeling of the anti-tissue factor pathway inhibitor antibody MG1113 in cynomolgus monkeys and rabbits.Frontiers in pharmacology · 2025Article
- Expansion of platform physiologically-based pharmacokinetic model for monoclonal antibodies towards different preclinical species: cats, sheep, and dogs.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells.Nature cancer · 2024Article
- A Minimal PBPK/PD Model with Expansion-Enhanced Target-Mediated Drug Disposition to Support a First-in-Human Clinical Study Design for a FLT3L-Fc Molecule.Pharmaceutics · 2024Article
- Kinetic modeling of the plasma pharmacokinetic profiles of ADAMTS13 fragment and its Fc-fusion counterpart in mice.Frontiers in pharmacology · 2024Article
- Immunoglobulin therapies for primary immunodeficiency diseases (part 1): understanding the pharmacokinetics.Immunotherapy · 2024Review
- Utility of Minimal Physiologically Based Pharmacokinetic Models for Assessing Fractional Distribution, Oral Absorption, and Series-Compartment Models of Hepatic Clearance.Drug metabolism and disposition: the biological fate of chemicals · 2023Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
purposeTo examine the across-species scalability of monoclonal antibody (mAb) pharmacokinetics (PK) and assess similarities in tissue distribution across species using a recently developed minimal PBPK (mPBPK) model.
methodsTwelve sets of antibody PK data from various species were obtained from the literature, which were jointly and individually analyzed. In joint analysis, vascular reflection coefficients for tissues with either tight (σ 1 ) or leaky endothelium (σ 2 ) were assumed consistent across species with systemic clearance allometrically scaled (CL = a∙BW (b) ). Four parameters (σ 1 , σ 2 , a, and b) were estimated in the joint analysis. In addition, the PK from each species was individually analyzed to assess species similarities in tissue distribution.
resultsTwelve mAb PK profiles were well-captured by the mPBPK model in the joint analysis. The estimated σ 1 ranged 0.690 to 0.999 with an average of 0.908; and σ 2 ranged 0.258 to 0.841 with an average of 0.579. Clearance was reasonably scaled and b ranged 0.695 to 1.27 averaging 0.91. Predictions of plasma concentrations for erlizumab and canakinumab in humans using parameters obtained from fitting animal data were consistent with actual measurements.
conclusionsTherapeutic mAbs given IV usually exhibit biexponential kinetics with their distribution properties best captured using physiological concepts. The mPBPK modeling approach may facilitate efforts in translating antibody distribution and overall PK across species.
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