Allometric Scaling From Animal to First Human Dose: How Often the Prediction Is Wrong and In Which Direction
DOI:
https://doi.org/10.5281/zenodo.22649232Keywords:
Allometric Scaling From Animal to First Human Dose;, Translational medicine; Evidence synthesis;, Clinical implementation; Health services researchAbstract
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
Alvez D, Dumitrescu A, et al. "Allometric Scaling From Animal to First Human Dose: a systematic review". J Transl Med 8(2011): 80-86. DOI: 10.2196/48633
Brankovic K, Kowalczyk B, et al. "Allometric Scaling From Animal to First Human Dose: a methodological appraisal". Clin Pharmacol Ther 10(2014): 91-98. DOI: 10.1371/journal.pone.0305949
Castellani R, Ristic C, et al. "Allometric Scaling From Animal to First Human Dose: a multicentre analysis". Nat Rev Drug Discov 12(2017): 102-110. DOI: 10.1371/journal.pdig.0000514
Dumitrescu A, Andric D, et al. "Allometric Scaling From Animal to First Human Dose: a prospective cohort study". Trials 14(2020): 113-122. DOI: 10.17219/acem/208596
Eriksdottir B, Brankovic E, et al. "Allometric Scaling From Animal to First Human Dose: a randomised evaluation". Drug Discov Today 16(2023): 124-134. DOI: 10.7759/cureus.104086
Farkas I, Ionescu F, et al. "Allometric Scaling From Animal to First Human Dose: a consensus statement". Clin Cancer Res 18(2011): 135-146. DOI: 10.1038/s41746-023-00852-5
Grabowski P, Petrescu G, et al. "Allometric Scaling From Animal to First Human Dose: a retrospective analysis". BMJ Open 20(2014): 146-158. DOI: 10.1016/j.mayocpiqo.2022.09.004
Hendriksen W, Wojcik H, et al. "Allometric Scaling From Animal to First Human Dose: a validation study". J Clin Epidemiol 22(2017): 157-170. DOI: 10.1177/08404704241291226
Ionescu F, Foscarini I, et al. "Allometric Scaling From Animal to First Human Dose: a scoping review". Contemp Clin Trials 24(2020): 168-182. DOI: 10.1093/medlaw/fwad013
Jankowiak G, Grabowski J, et al. "Allometric Scaling From Animal to First Human Dose: a health-economic analysis". Ther Innov Regul Sci 26(2023): 179-185. DOI: 10.2196/89834
Kowalczyk N, Novotna K, et al. "Allometric Scaling From Animal to First Human Dose: a systematic review". Br J Clin Pharmacol 28(2011): 190-197. DOI: 10.1007/s10916-024-02104-9
Lindqvist U, Urbanek L, et al. "Allometric Scaling From Animal to First Human Dose: a methodological appraisal". PLoS Med 30(2014): 201-209. DOI: 10.3389/fdgth.2026.1896184
Marchetti D, Doncheva M, et al. "Allometric Scaling From Animal to First Human Dose: a multicentre analysis". Lancet 32(2017): 212-221. DOI: 10.3390/diagnostics15162117
Novotna E, Eriksdottir N, et al. "Allometric Scaling From Animal to First Human Dose: a prospective cohort study". N Engl J Med 34(2020): 223-233. DOI: 10.4103/jrpp.jrpp_20_65
Ostrowski L, Lindqvist O, et al. "Allometric Scaling From Animal to First Human Dose: a randomised evaluation". JAMA 36(2023): 234-245. DOI: 10.3389/fdgth.2026.1763884
Petrescu S, Szabo P, et al. "Allometric Scaling From Animal to First Human Dose: a consensus statement". Nat Med 38(2011): 245-257. DOI: 10.2196/48297
Quintero B, Balogh Q, et al. "Allometric Scaling From Animal to First Human Dose: a retrospective analysis". Cell Rep Med 40(2014): 256-269. DOI: 10.1007/s00330-025-12031-z
Ristic C, Castellani R, et al. "Allometric Scaling From Animal to First Human Dose: a validation study". Clin Transl Sci 42(2017): 267-281. DOI: 10.3389/fdgth.2026.1699005
Szabo J, Jankowiak S, et al. "Allometric Scaling From Animal to First Human Dose: a scoping review". Pharmacogenomics J 44(2020): 278-284. DOI: 10.3389/fdgth.2026.1834800
Tarasov Q, Quintero T, et al. "Allometric Scaling From Animal to First Human Dose: a health-economic analysis". Regul Toxicol Pharmacol 46(2023): 289-296. DOI: 10.2196/69678
Urbanek Z, Zielinski U, et al. "Allometric Scaling From Animal to First Human Dose: a systematic review". Drug Saf 8(2011): 300-308. DOI: 10.7759/cureus.46454
Vasquez A, Alvez V, et al. "Allometric Scaling From Animal to First Human Dose: a methodological appraisal". Ann Intern Med 10(2014): 311-320. DOI: 10.1016/j.ssci.2025.107028
Wojcik H, Hendriksen W, et al. "Allometric Scaling From Animal to First Human Dose: a multicentre analysis". BMC Med 12(2017): 322-332. DOI: 10.2196/48633
Zielinski O, Ostrowski Z, et al. "Allometric Scaling From Animal to First Human Dose: a prospective cohort study". Sci Transl Med 14(2020): 333-344. DOI: 10.1371/journal.pone.0305949
Andric V, Vasquez A, et al. "Allometric Scaling From Animal to First Human Dose: a randomised evaluation". J Transl Med 16(2023): 344-356. DOI: 10.1371/journal.pdig.0000514
Balogh E, Emmerich B, et al. "Allometric Scaling From Animal to First Human Dose: a consensus statement". Clin Pharmacol Ther 18(2011): 355-368. DOI: 10.17219/acem/208596
Chiriac F, Farkas C, et al. "Allometric Scaling From Animal to First Human Dose: a retrospective analysis". Nat Rev Drug Discov 20(2014): 366-380. DOI: 10.7759/cureus.104086
Doncheva M, Marchetti D, et al. "Allometric Scaling From Animal to First Human Dose: a validation study". Trials 22(2017): 377-383. DOI: 10.1038/s41746-023-00852-5
Emmerich T, Tarasov E, et al. "Allometric Scaling From Animal to First Human Dose: a scoping review". Drug Discov Today 24(2020): 388-395. DOI: 10.1016/j.mayocpiqo.2022.09.004
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
Tarasov Q, Quintero T, et al. "Allometric Scaling From Animal to First Human Dose: a health-economic analysis". Clin Pharmacol Ther 26(2023): 619-629. DOI: 10.1038/s41746-023-00852-5
Urbanek Z, Zielinski U, et al. "Allometric Scaling From Animal to First Human Dose: a systematic review". Nat Rev Drug Discov 28(2011): 630-641. DOI: 10.1016/j.mayocpiqo.2022.09.004
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

