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

dc.contributor.authorHenze, Laura J.
dc.contributor.authorKoehl, Niklas J.
dc.contributor.authorO'Shea, Joseph P.
dc.contributor.authorKostewicz Edmund
dc.contributor.authorHolm, René
dc.contributor.authorGriffin, Brendan T.
dc.contributor.funderHorizon 2020en
dc.date.accessioned2018-04-17T11:03:14Z
dc.date.available2018-04-17T11:03:14Z
dc.date.issued2018-04-10
dc.date.updated2018-04-17T10:37:43Z
dc.description.abstractObjectives: 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.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationHenze, 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.12912en
dc.identifier.doi10.1111/jphp.12912
dc.identifier.endpage602en
dc.identifier.issn0022-3573
dc.identifier.issn2042-7158
dc.identifier.issued4
dc.identifier.journaltitleJournal of Pharmacy and Pharmacologyen
dc.identifier.startpage581en
dc.identifier.urihttps://hdl.handle.net/10468/5790
dc.identifier.volume71
dc.language.isoenen
dc.publisherWileyen
dc.relation.projectinfo: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/PEARRLen
dc.relation.urihttps://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.subjectMinipigsen
dc.subjectOral drug absorptionen
dc.subjectPhysiologically based pharmacokineticen
dc.subjectPigsen
dc.subjectPreclinical animal modelen
dc.subjectPBPKen
dc.titleThe pig as a pre-clinical model for predicting oral bioavailability and in vivo performance of pharmaceutical oral dosage forms - a PEARRL reviewen
dc.typeArticle (peer-reviewed)en
Files
Original bundle
Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
5258_Laura_J__Henze-manuscript_JPP.pdf
Size:
796.14 KB
Format:
Adobe Portable Document Format
Description:
Accepted version
License bundle
Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
license.txt
Size:
2.71 KB
Format:
Item-specific license agreed upon to submission
Description: