Evidence map›Paper›PMID 39846610›Full record

ArticleAntibodies (Basel, Switzerland)2024

Rat as a Predictive Model for Human Clearance and Bioavailability of Monoclonal Antibodies.

Jason D Robarge, Kevin M Budge, Lucy Her, Andrea M Patterson, Patricia Brown-Augsburger

Abstract read
In one paragraph

Article in Antibodies (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. The Effects of Radioimmunotherapy and Antibiotics on Biofilm-Associated Implant Infections in a Preclinical Rat Model.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2026
    Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Jason D RobargeEli Lilly and Company, Lilly Corporate Center Indianapolis, Indianapolis, IN 46285, USA.ORCID 0000-0001-8941-1153
Kevin M BudgeEli Lilly and Company, Lilly Corporate Center Indianapolis, Indianapolis, IN 46285, USA.
Lucy HerEli Lilly and Company, Lilly Corporate Center Indianapolis, Indianapolis, IN 46285, USA.ORCID 0000-0003-0340-2323
Andrea M PattersonEli Lilly and Company, Lilly Corporate Center Indianapolis, Indianapolis, IN 46285, USA.
Patricia Brown-AugsburgerEli Lilly and Company, Lilly Corporate Center Indianapolis, Indianapolis, IN 46285, USA.

Funding

Eli Lilly and Company N/A
6 · The paper itself

Abstract

backgroundThe prediction of human clearance (CL) and subcutaneous (SC) bioavailability is a critical aspect of monoclonal antibody (mAb) selection for clinical development. While monkeys are a well-accepted model for predicting human CL, other preclinical species have been less-thoroughly explored. Unlike CL, predicting the bioavailability of SC administered mAbs in humans remains challenging as contributing factors are not well understood, and preclinical models have not been systematically evaluated.

methodsNon-clinical and clinical pharmacokinetic (PK) parameters were mined from public and internal sources for rats, cynomolgus monkeys, and humans. Intravenous (IV) and SC PK was determined in Sprague Dawley rats for fourteen mAbs without existing PK data. Together, we obtained cross-species data for 25 mAbs to evaluate CL and SC bioavailability relationships among rats, monkeys, and humans.

resultsRat and monkey CL significantly correlated with human CL and supported the use of species-specific exponents for body-weight-based allometric scaling. Notably, rat SC bioavailability significantly correlated with human SC bioavailability, while monkey SC bioavailability did not. Bioavailability also correlated with clearance.

conclusionsThe rat model enables an early assessment of mAb PK properties, allowing discrimination among molecules in the discovery pipeline and prediction of human PK. Importantly, rat SC bioavailability significantly correlated with human SC bioavailability, which has not been observed with other species. Rats are cost-effective and efficient relative to monkeys and provide a valuable tool for pharmacokinetic predictions in therapeutic antibody discovery.

Indexed as

allometric scalingbioavailabilityclearancemonoclonal antibodypharmacokineticsrat

Identifiers

PMID39846610
PMCPMC11755617

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Registered trials

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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.