The pig as a pre-clinical model for predicting oral bioavailability and in vivo performance of pharmaceutical oral dosage forms - a PEARRL review

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dc.contributor.author Henze, Laura J.
dc.contributor.author Koehl, Niklas J.
dc.contributor.author O'Shea, Joseph P.
dc.contributor.author Kostewicz Edmund
dc.contributor.author Holm, René
dc.contributor.author Griffin, Brendan T.
dc.date.accessioned 2018-04-17T11:03:14Z
dc.date.available 2018-04-17T11:03:14Z
dc.date.issued 2018-04-10
dc.identifier.citation Henze, L. J., Koehl, N. J., O'Shea, J. P., Kostewicz, E. S., Holm, R. and Griffin, B. T. (2018) 'The pig as a preclinical model for predicting oral bioavailability and in vivo performance of pharmaceutical oral dosage forms: a PEARRL review', Journal of Pharmacy and Pharmacology, 71 (4), pp. 581-602 doi:10.1111/jphp.12912 en
dc.identifier.volume 71
dc.identifier.issued 4
dc.identifier.startpage 581 en
dc.identifier.endpage 602 en
dc.identifier.issn 0022-3573
dc.identifier.issn 2042-7158
dc.identifier.uri http://hdl.handle.net/10468/5790
dc.identifier.doi 10.1111/jphp.12912
dc.description.abstract Objectives: In pharmaceutical drug development, preclinical tests in animal models are essential to demonstrate whether the new drug is orally bioavailable and to gain a first insight into in vivo pharmacokinetic parameters that can subsequently be used to predict human values. Despite significant advances in the development of bio‐predictive in vitro models and increasing ethical expectations for reducing the number of animals used for research purposes, there is still a need for appropriately selected pre‐clinical in vivo testing to provide guidance on the decision to progress to testing in humans. The selection of the appropriate animal models is essential both to maximise the learning that can be obtained from such experiments and to avoid unnecessary testing in a range of species. Key findings: The present review, provides an insight into the suitability of the pig model for predicting oral bioavailability in humans, by comparing the conditions in the GIT. It also contains a comparison between the bioavailability of compounds dosed to both humans and pigs, to provide an insight into the relative correlation and examples on why a lack of correlation may be observed. Summary: While there is a general trend towards predicting human bioavailability from pig data, there is considerable variability in the data set, most likely reflecting species specific differences in individual drug metabolism. Nonetheless, the correlation between pigs vs. humans was comparable to that reported for dogs vs. humans. The presented data demonstrate the suitability of the pig as a preclinical model to predict bioavailability in human. en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Wiley en
dc.relation.uri https://onlinelibrary.wiley.com/doi/epdf/10.1111/jphp.12912
dc.rights © 2018 Royal Pharmaceutical Society. This is the peer reviewed version of the following article: (2018), The pig as a preclinical model for predicting oral bioavailability and in vivo performance of pharmaceutical oral dosage forms: a PEARRL review. J Pharm Pharmacol., which has been published in final form at https://doi.org/10.1111/jphp.12912. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving. en
dc.subject Minipigs en
dc.subject Oral drug absorption en
dc.subject Physiologically based pharmacokinetic en
dc.subject Pigs en
dc.subject Preclinical animal model en
dc.subject PBPK en
dc.title The pig as a pre-clinical model for predicting oral bioavailability and in vivo performance of pharmaceutical oral dosage forms - a PEARRL review en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Laura J. Henze, School Of Pharmacy, University College Cork, Cork, Ireland. +353-21-490-3000 Email: laura.henze@ucc.ie en
dc.internal.availability Full text available en
dc.date.updated 2018-04-17T10:37:43Z
dc.description.version Accepted Version en
dc.internal.rssid 431799837
dc.contributor.funder Horizon 2020 en
dc.description.status Peer reviewed en
dc.identifier.journaltitle Journal of Pharmacy and Pharmacology en
dc.internal.copyrightchecked No !!CORA!! en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress brendan.griffin@ucc.ie en
dc.internal.IRISemailaddress laura.henze@ucc.ie en
dc.internal.IRISemailaddress niklas.koehl@ucc.ie en
dc.relation.project info:eu-repo/grantAgreement/EC/H2020::MSCA-ITN-ETN/674909/EU/Pharmaceutical Education And Research with Regulatory Links: Innovative drug development strategies and regulatory tools tailored to facilitate earlier access to medicines/PEARRL en


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