Author(s): Musther H, OlivaresMorales A, Hatley OJ, Liu B, Rostami Hodjegan A
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Abstract Oral bioavailability is a key consideration in development of drug products, and the use of preclinical species in predicting bioavailability in human has long been debated. In order to clarify whether any correlation between human and animal bioavailability exist, an extensive analysis of the published literature data was conducted. Due to the complex nature of bioavailability calculations inclusion criteria were applied to ensure integrity of the data. A database of 184 compounds was assembled. Linear regression for the reported compounds indicated no strong or predictive correlations to human data for all species, individually and combined. The lack of correlation in this extended dataset highlights that animal bioavailability is not quantitatively predictive of bioavailability in human. Although qualitative (high/low bioavailability) indications might be possible, models taking into account species-specific factors that may affect bioavailability are recommended for developing quantitative prediction. Copyright © 2013 Elsevier B.V. All rights reserved.
This article was published in Eur J Pharm Sci
and referenced in Journal of Molecular Pharmaceutics & Organic Process Research