Animal Models Used for Bioavailability and Bioequivalence Studies: Focus on Their Human Likeness

Authors: Sudhakar P*, Sirisha K, Monika M, SelvaPreethi S and Anjali G

DOI: 10.23880/beba-16000198

Volume 7, Issue 1

Abstract

Bioequivalence (BE) and bioavailability (BA) studies are important for the development of new drugs and their approval by regulatory agencies. To determine the safety and efficacy of a drug, it is necessary to evaluate its bioavailability and bioequivalence. In vivo preclinical studies of BEBA are needed to explore the pharmacokinetic properties and behaviour of drugs. The in vivo BEBA studies data helps to get the proximate pharmacokinetic human values for clinical studies. The selection of animal models for BEBA studies plays a crucial role, which should mimic the anatomical and physiological state of humans. In this study, we have extensively reviewed the commonly used animal models for BEBA studies i.e. rodents, rabbits, canines, pigs, and non-human primates, and their relevance with human physiology. Besides the selected models rats have similar absorption, distribution, metabolism, and excretion profile to humans. Beagle dogs are an alternative commonly used in the study of oral bioavailability, as they share many similarities with humans in terms of gastrointestinal anatomy and physiology. This extensive review provides valuable information about the selection of proper animal models for BEBA studies.

Keywords: Animal Models; Bioavailability; Bioequivalence; Pharmacokinetics

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