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Review
. 2016 Mar;7(2):27-31.
doi: 10.4103/0976-0105.177703.

A simple practice guide for dose conversion between animals and human

Anroop B Nair  1 , Shery Jacob  2
Affiliations
Review

A simple practice guide for dose conversion between animals and human

Anroop B Nair et al. J Basic Clin Pharm. 2016 Mar.

Abstract

Understanding the concept of extrapolation of dose between species is important for pharmaceutical researchers when initiating new animal or human experiments. Interspecies allometric scaling for dose conversion from animal to human studies is one of the most controversial areas in clinical pharmacology. Allometric approach considers the differences in body surface area, which is associated with animal weight while extrapolating the doses of therapeutic agents among the species. This review provides basic information about translation of doses between species and estimation of starting dose for clinical trials using allometric scaling. The method of calculation of injection volume for parenteral formulation based on human equivalent dose is also briefed.

Keywords: Calculation; clinical trials; experiment; extrapolation; parenteral; species; starting dose; translation.

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Figures

Figure 1
Figure 1
Schematic representation of five steps to estimate starting dose in human studies
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References

    1. Reigner BG, Blesch KS. Estimating the starting dose for entry into humans: Principles and practice. Eur J Clin Pharmacol. 2002;57:835–45. - PubMed
    1. Contrera JF, Matthews EJ, Kruhlak NL, Benz RD. Estimating the safe starting dose in phase I clinical trials and no observed effect level based on QSAR modeling of the human maximum recommended daily dose. Regul Toxicol Pharmacol. 2004;40:185–206. - PubMed
    1. Lavé T, Luttringer O, Poulin P, Parrott N. Interspecies scaling. In: Krishna R, editor. Applications of Pharmacokinetic Principles in Drug Development. New York: Springer Science and Business Media, LLC; 2004. pp. 133–75.
    1. Sharma V, McNeill JH. To scale or not to scale: The principles of dose extrapolation. Br J Pharmacol. 2009;157:907–21. - PMC - PubMed
    1. Chaturvedi PR, Decker CJ, Odinecs A. Prediction of pharmacokinetic properties using experimental approaches during early drug discovery. Curr Opin Chem Biol. 2001;5:452–63. - PubMed