A simple practice guide for dose conversion between animals and human

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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.

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Most cited references 11

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It has been known for decades that the metabolic rate of animals scales with body mass with an exponent that is almost always 2/3, and often very close to 3/4. The 3/4 exponent emerges naturally from two models of resource distribution networks, radial explosion and hierarchically branched, which incorporate a minimum of specific details. Both models show that the exponent is 2/3 if velocity of flow remains constant, but can attain a maximum value of 3/4 if velocity scales with its maximum exponent, 1/12. Quarter-power scaling can arise even when there is no underlying fractality. The canonical "fourth dimension" in biological scaling relations can result from matching the velocity of flow through the network to the linear dimension of the terminal "service volume" where resources are consumed. These models have broad applicability for the optimal design of biological and engineered systems where energy, materials, or information are distributed from a single source.

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Quantitative estimations of first-in-human (FIH) doses are critical for phase I clinical trials in drug development. Human pharmacokinetic (PK) prediction methods have been developed to project the human clearance (CL) and bioavailability with reasonable accuracy, which facilitates estimation of a safe yet efficacious FIH dose. However, the FIH dose estimation is still very challenging and complex. The aim of this article is to review the common approaches for FIH dose estimation with an emphasis on PK-guided estimation. We discuss 5 methods for FIH dose estimation, 17 approaches for the prediction of human CL, 6 methods for the prediction of bioavailability, and 3 tools for the prediction of PK profiles. This review may serve as a practical protocol for PK- or pharmacokinetic/pharmacodynamic-guided estimation of the FIH dose.

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Author and article information

Journal

Journal ID (nlm-ta): J Basic Clin Pharm

Journal ID (iso-abbrev): J Basic Clin Pharm

Journal ID (publisher-id): JBCP

Title: Journal of Basic and Clinical Pharmacy

Publisher: Medknow Publications & Media Pvt Ltd (India )

ISSN (Print): 0976-0105

ISSN (Electronic): 0976-0113

Publication date (Print): March 2016-May 2016

Volume: 7

Issue: 2

Pages: 27-31

Affiliations

[1] Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa, Kingdom of Saudi Arabia

[1 ] Department of Pharmaceutics, College of Pharmacy, Gulf Medical University, Ajman, UAE

Author notes

Address for correspondence: Dr. Anroop B. Nair, Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, P.O. Box 400, Al-Ahsa 31982, Kingdom of Saudi Arabia. E-mail: anair@ 123456kfu.edu.sa

Article

Publisher ID: JBCP-7-27

DOI: 10.4103/0976-0105.177703

PMC ID: 4804402

PubMed ID: 27057123

SO-VID: d61d191b-47a9-443a-8419-5ba34b69bf43

License:

This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

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