Animal versus human oral drug bioavailability: Do they correlate?

Helen Musther, Andrés Olivares-Morales, Oliver J D Hatley, Bo Liu, Amin Rostami Hodjegan

    Research output: Contribution to journalArticlepeer-review

    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. © 2013 Elsevier B.V. All rights reserved.
    Original languageEnglish
    Pages (from-to)280-291
    Number of pages11
    JournalEuropean Journal of Pharmaceutical Sciences
    Volume57
    Issue number1
    Early online date26 Aug 2013
    DOIs
    Publication statusPublished - 16 Jun 2014

    Keywords

    • Drug development
    • First in man pharmacokinetics
    • Oral drug absorption

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