Dose translation from animal to human studies revisited.

Reagan‐Shaw, Shannon; Nihal, Minakshi; Ahmad, Nihal

doi:10.1096/fj.07-9574lsf

Cited by 6,524Animal testing and alternativesPharmaceutical studies and practicesStatistical Methods in Clinical Trials

Dose translation from animal to human studies revisited.

Reagan‐Shaw, Shannon, Nihal, Minakshi, Ahmad, Nihal·2008·The FASEB Journal

DOI 10.1096/fj.07-9574lsf

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Abstract

As new drugs are developed, it is essential to appropriately translate the drug dosage from one animal species to another. A misunderstanding appears to exist regarding the appropriate method for allomet‐ric dose translations, especially when starting new animal or clinical studies. The need for education regarding appropriate translation is evident from the media response regarding some recent studies where authors have shown that resveratrol, a compound found in grapes and red wine, improves the health and life span of mice. Immediately after the online publication of these papers, the scientific community and popular press voiced concerns regarding the relevance of the dose of resveratrol used by the authors. The animal dose should not be extrapolated to a human equivalent dose (HED) by a simple conversion based on body weight, as was reported. For the more appropriate conversion of drug doses from animal studies to human studies, we suggest using the body surface area (BSA) normalization method. BSA correlates well across several mammalian species with several parameters of biology, including oxygen utilization, caloric expenditure, basal metabolism, blood volume, circulating plasma proteins, and renal function. We advocate the use of BSA as a factor when converting a dose for translation from animals to humans, especially for phase I and phase II clinical trials.—Reagan‐Shaw S., Nihal, M., Ahmad N. Dose translation from animal to human studies revisited. FASEB J . 22, 659–661 (2007)

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The dose of each SSRI administered in mice was within the range of what would be prescribed to human patients to treat depression, taking into account species differences in metabolism.
“The dose of each SSRI administered in mice was within the range of what would be prescribed to human patients to treat depression (taking into account species differences in metabolism) (23).”
From Serotonin signaling is associated with lower amyloid-β levels and plaques in transgenic mice and humans (2011) · cites this paper as [23]
The dose of atorvastatin 40 mg/Kg in mice is equivalent to 3.24 mg/Kg in humans based on FDA mouse-to-human dose translation guidelines.
“Worth noting is that the dose of each atorvastatin injection administered to mice in the study at hand, 40 mg/Kg, is equivalent to a dose of 3.24 mg/Kg in man based on United States Food and Drug Administration (FDA) mouse to human dose translation guidelines (Reagan-Shaw et al., 2008).”
From Atorvastatin Reduces the Survival of Candida albicans-Infected BALB/c Mice (2015) · cites this paper as Reagan-Shaw et al., 2008

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Authors: Reagan‐Shaw, S., Nihal, M., & Ahmad, N.
Affiliations: University of Wisconsin–Madison (US)
ORCID: Nihal, Minakshi
Ahmad, Nihal
Venue: The FASEB Journal
Publisher: Wiley
Published: 2007-10-17
Volume: 22
Issue: 3
Pages: 659-661
ISSN: 0892-6638 (ISSN-L)
1530-6860
DOI: 10.1096/fj.07-9574lsf
OpenAlex: W2121836743
Cited by: 6,524
References: 21
Citations by year: 2026: 547 · 2025: 532 · 2024: 429 · 2023: 419 · 2022: 453 · 2021: 464 · 2020: 471 · 2019: 374 · 2018: 400 · 2017: 401 · 2016: 414 · 2015: 412 · 2014: 353 · 2013: 290 · 2012: 232
FWCI: 83.19
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: The FASEB Journal (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: allometric scaling, human equivalent dose, body surface area normalization, animal-to-human extrapolation, resveratrol, drug dosing
MeSH terms: Animals, Body Surface Area, Clinical Trials as Topic, Dose-Response Relationship, Drug, Humans, Species Specificity, Therapeutic Equivalency, Models, Animal, Mice

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Dose translation from animal to human studies revisited.

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