Animal versus human oral drug bioavailability: do they correlate?

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
Helen MustherAmin Rostami Hodjegan

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.

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Citations

Sep 28, 2013·Pharmaceutical Research·Andrés Olivares-MoralesAmin Rostami-Hodjegan
Jul 22, 2014·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Joost WesterhoutHeleen M Wortelboer
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Nov 18, 2014·Clinical and Experimental Pharmacology & Physiology·Weihong ZhaoJian Zhang
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Jun 14, 2016·Journal of Controlled Release : Official Journal of the Controlled Release Society·Abhijit A DateLaura M Ensign
Feb 6, 2017·Biopharmaceutics & Drug Disposition·Estelle YauSheila Annie Peters
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