ArticleClinical and translational science2019
Prediction of Human Pharmacokinetics of Antibody-Drug Conjugates From Nonclinical Data.
Article in Clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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.
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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
16 citing papers in PubMed, 28 citations in OpenAlex.
- Human Pharmacokinetic Prediction of Antibody-Drug Conjugates Using Human FcRn Transgenic Mice.Clinical and translational science · 2026Article
- Population-Based Modeling to Predict Human PK/PD of TAK-500, an Anti-CCR2 Antibody-Drug Conjugate for First-in-Human Study in Cancer Patients.Clinical and translational science · 2026Article
- Pharmacometric modeling of lipid nanoparticle-encapsulated mRNA therapeutics and vaccines: A systematic review.Molecular therapy. Nucleic acids · 2025Review
- Preclinical pharmacokinetics, distribution, metabolism and excretion of disitamab vedotin.ADMET & DMPK · 2025Article
- QSP modeling of a transiently inactivating antibody-drug conjugate highlights benefit of short antibody half life.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- An Evaluation of First-in-Human Studies for RNA Oligonucleotides.Nucleic acid therapeutics · 2024Review
- Key considerations based on pharmacokinetic/pharmacodynamic in the design of antibody-drug conjugates.Frontiers in oncology · 2024Review
- Pharmacokinetic evaluation of radiolabeled intraocular anti-CLEC14a antibody in preclinical animal species and application in humans.Clinical and translational science · 2022Article
- A Simple Method for the Prediction of Human Concentration-Time Profiles and Pharmacokinetics of Antibody-Drug Conjugates (ADC) from Rats or Monkeys.Antibodies (Basel, Switzerland) · 2022Article
- Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Clinical pharmacology strategies in supporting drug development and approval of antibody-drug conjugates in oncology.Cancer chemotherapy and pharmacology · 2021Review
- Clinical Pharmacology of Antibody-Drug Conjugates.Antibodies (Basel, Switzerland) · 2021Review
- Interspecies Scaling of Antibody-Drug Conjugates (ADC) for the Prediction of Human Clearance.Antibodies (Basel, Switzerland) · 2021Article
- Integrated whole liver histologic analysis of the allogeneic islet distribution and characteristics in a nonhuman primate model.Scientific reports · 2020Article
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Corrections and comments
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Authors and funding
18 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Prediction of human pharmacokinetics (PK) based on preclinical information for antibody-drug conjugates (ADCs) provide important insight into first-in-human (FIH) study design. This retrospective analysis was conducted to identify an appropriate scaling method to predict human PK for ADCs from animal PK data in the linear range. Different methods for projecting human clearance (CL) from animal PK data for 11 ADCs exhibiting linear PK over the tested dose ranges were examined: multiple species allometric scaling (CL vs. body weight), allometric scaling with correction factors, allometric scaling based on rule of exponent, and scaling from only cynomolgus monkey PK data. Two analytes of interest for ADCs, namely total antibody and conjugate (measured as conjugated drug or conjugated antibody), were assessed. Percentage prediction errors (PEs) and residual sum of squares (RSS) were compared across methods. Human CL was best estimated using cynomolgus monkey PK data alone and an allometric scaling exponent of 1.0 for CL. This was consistently observed for both conjugate and total antibody analytes. Other scaling methods either underestimated or overestimated human CL, or produced larger average absolute PEs and RSS. Human concentration-time profiles were also reasonably predicted from the cynomolgus monkey data using species-invariant time method with a fixed exponent of 1.0 for CL and 1.0 for volume of distribution. In conclusion, results from this retrospective analysis of 11 ADCs indicate that allometric scaling of CL with an exponent of 1.0 using cynomolgus monkey PK data alone can successfully project human PK profiles of an ADC within linear range.
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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.