Allometric Scaling From Animal to First Human Dose: How Often the Prediction Is Wrong and In Which Direction

Authors

  • Razvan Barbulescu Department of Pharmacokinetics, Harghita Institute of Translational Medicine, Miercurea Ciuc, Romania Author
  • Renata Sivakova Centre for Preclinical Modelling, Liptov Institute of Translational Medicine, Liptovsky Mikulas, Slovakia Author
  • Elisabeth Ebenhoch Department of Biostatistics, Weinviertel Institute of Translational Medicine, Mistelbach, Austria Author

DOI:

https://doi.org/10.5281/zenodo.22649232

Keywords:

Allometric Scaling From Animal to First Human Dose;, Translational medicine; Evidence synthesis;, Clinical implementation; Health services research

Abstract

Allometric Scaling From Animal to First Human Dose is an area of active development in translational medicine, with evidence
that has accumulated unevenly across its component questions. We review the current evidence base for allometric scaling from
animal to first human dose, spanning analytical, clinical, implementation, governance, and economic dimensions, focusing on
where practice has converged and where it continues to vary, and set out the practical considerations relevant to a service
considering its adoption. We conclude that selective, context-specific use is best supported by the evidence currently available,
rather than uniform adoption or avoidance.

References

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Foscarini C, Chiriac F, et al. "Allometric Scaling From Animal to First Human Dose: a health-economic analysis". Clin Cancer Res 26(2023): 399-407. DOI: 10.1177/08404704241291226

Alvez D, Dumitrescu A, et al. "Allometric Scaling From Animal to First Human Dose: a systematic review". BMJ Open 28(2011): 410-419. DOI: 10.1093/medlaw/fwad013

Brankovic K, Kowalczyk B, et al. "Allometric Scaling From Animal to First Human Dose: a methodological appraisal". J Clin Epidemiol 30(2014): 421-431. DOI: 10.2196/89834

Castellani R, Ristic C, et al. "Allometric Scaling From Animal to First Human Dose: a multicentre analysis". Contemp Clin Trials 32(2017): 432-443. DOI: 10.1007/s10916-024-02104-9

Dumitrescu A, Andric D, et al. "Allometric Scaling From Animal to First Human Dose: a prospective cohort study". Ther Innov Regul Sci 34(2020): 443-455. DOI: 10.3389/fdgth.2026.1896184

Eriksdottir B, Brankovic E, et al. "Allometric Scaling From Animal to First Human Dose: a randomised evaluation". Br J Clin Pharmacol 36(2023): 454-467. DOI: 10.3390/diagnostics15162117

Farkas I, Ionescu F, et al. "Allometric Scaling From Animal to First Human Dose: a consensus statement". PLoS Med 38(2011): 465-479. DOI: 10.4103/jrpp.jrpp_20_65

Grabowski P, Petrescu G, et al. "Allometric Scaling From Animal to First Human Dose: a retrospective analysis". Lancet 40(2014): 476-482. DOI: 10.3389/fdgth.2026.1763884

Hendriksen W, Wojcik H, et al. "Allometric Scaling From Animal to First Human Dose: a validation study". N Engl J Med 42(2017): 487-494. DOI: 10.2196/48297

Ionescu F, Foscarini I, et al. "Allometric Scaling From Animal to First Human Dose: a scoping review". JAMA 44(2020): 498-506. DOI: 10.1007/s00330-025-12031-z

Jankowiak G, Grabowski J, et al. "Allometric Scaling From Animal to First Human Dose: a health-economic analysis". Nat Med 46(2023): 509-518. DOI: 10.3389/fdgth.2026.1699005

Kowalczyk N, Novotna K, et al. "Allometric Scaling From Animal to First Human Dose: a systematic review". Cell Rep Med 8(2011): 520-530. DOI: 10.3389/fdgth.2026.1834800

Lindqvist U, Urbanek L, et al. "Allometric Scaling From Animal to First Human Dose: a methodological appraisal". Clin Transl Sci 10(2014): 531-542. DOI: 10.2196/69678

Marchetti D, Doncheva M, et al. "Allometric Scaling From Animal to First Human Dose: a multicentre analysis". Pharmacogenomics J 12(2017): 542-554. DOI: 10.7759/cureus.46454

Novotna E, Eriksdottir N, et al. "Allometric Scaling From Animal to First Human Dose: a prospective cohort study". Regul Toxicol Pharmacol 14(2020): 553-566. DOI: 10.1016/j.ssci.2025.107028

Ostrowski L, Lindqvist O, et al. "Allometric Scaling From Animal to First Human Dose: a randomised evaluation". Drug Saf 16(2023): 564-578. DOI: 10.2196/48633

Petrescu S, Szabo P, et al. "Allometric Scaling From Animal to First Human Dose: a consensus statement". Ann Intern Med 18(2011): 575-581. DOI: 10.1371/journal.pone.0305949

Quintero B, Balogh Q, et al. "Allometric Scaling From Animal to First Human Dose: a retrospective analysis". BMC Med 20(2014): 586-593. DOI: 10.1371/journal.pdig.0000514

Ristic C, Castellani R, et al. "Allometric Scaling From Animal to First Human Dose: a validation study". Sci Transl Med 22(2017): 597-605. DOI: 10.17219/acem/208596

Szabo J, Jankowiak S, et al. "Allometric Scaling From Animal to First Human Dose: a scoping review". J Transl Med 24(2020): 608-617. DOI: 10.7759/cureus.104086

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Vasquez A, Alvez V, et al. "Allometric Scaling From Animal to First Human Dose: a methodological appraisal". Trials 30(2014): 641-653. DOI: 10.1177/08404704241291226

Wojcik H, Hendriksen W, et al. "Allometric Scaling From Animal to First Human Dose: a multicentre analysis". Drug Discov Today 32(2017): 652-665. DOI: 10.1093/medlaw/fwad013

Zielinski O, Ostrowski Z, et al. "Allometric Scaling From Animal to First Human Dose: a prospective cohort study". Clin Cancer Res 34(2020): 663-677. DOI: 10.2196/89834

Andric V, Vasquez A, et al. "Allometric Scaling From Animal to First Human Dose: a randomised evaluation". BMJ Open 36(2023): 674-680. DOI: 10.1007/s10916-024-02104-9

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Published

2024-01-11

How to Cite

Allometric Scaling From Animal to First Human Dose: How Often the Prediction Is Wrong and In Which Direction. (2024). Translational Medicine & Therapeutics Journal, 3(1), 1-9. https://doi.org/10.5281/zenodo.22649232

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