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dc.contributor.authorGrayling, Michael J
dc.contributor.authorMander, Adrian P
dc.contributor.authorWason, James MS
dc.date.accessioned2022-06-28T23:30:14Z
dc.date.available2022-06-28T23:30:14Z
dc.date.issued2019
dc.identifier.issn1946-6315
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/338407
dc.description.abstractBioequivalence (BE) studies are most often conducted as crossover trials, and therefore establishing their required sample size necessitates specification of the within-person variance. Given that this specification is often difficult in practice, there has been great interest in recent years in the use of adaptive designs for BE trials. However, while numerous methods for this have now been presented, their focus has been solely on two-treatment BE studies. In some instances, it will be desired to incorporate more than a single test and reference formulation into a BE trial. It would therefore be useful to establish methodology for the design of adaptive multi-treatment BE trials, to acquire the benefits in the two-treatment setting in this more complex situation. Here, we achieve this for three-treatment studies by extending previously proposed designs for two-treatment trials. First, we discuss the additional design considerations that arise when multiple comparisons are made. Next, an extensive simulation study is employed to compare the performance of the proposed procedures. With this, we demonstrate that two-stage designs with desirable statistical operating characteristics can be readily identified for three-treatment BE trials. Supplementary materials for this article are available online.
dc.format.mediumPrint-Electronic
dc.publisherInforma UK Limited
dc.rightsAttribution-NonCommercial 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/
dc.subjectInterim analysis
dc.subjectRe-estimation
dc.subjectSequential
dc.subjectUnblinded
dc.titleTwo-Stage Adaptive Designs for Three-Treatment Bioequivalence Studies.
dc.typeArticle
dc.publisher.departmentMrc Biostatistics Unit
dc.date.updated2022-06-21T12:39:35Z
prism.endingPage374
prism.issueIdentifier4
prism.publicationDate2019
prism.publicationNameStat Biopharm Res
prism.startingPage360
prism.volume11
dc.identifier.doi10.17863/CAM.85820
dcterms.dateAccepted2019-08-05
rioxxterms.versionofrecord10.1080/19466315.2019.1654911
rioxxterms.versionAM
dc.contributor.orcidGrayling, Michael [0000-0002-0680-6668]
dc.contributor.orcidMander, Adrian [0000-0002-0742-9040]
dc.contributor.orcidWason, James [0000-0002-4691-126X]
dc.identifier.eissn1946-6315
rioxxterms.typeJournal Article/Review
pubs.funder-project-idWellcome Trust (099770/Z/12/Z)
cam.issuedOnline2019-09-06
cam.orpheus.success2022-06-28 - Embargo set during processing via Fast-track
cam.depositDate2022-06-21
pubs.licence-identifierapollo-deposit-licence-2-1
pubs.licence-display-nameApollo Repository Deposit Licence Agreement
rioxxterms.freetoread.startdate2020-09-06


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Attribution-NonCommercial 4.0 International
Except where otherwise noted, this item's licence is described as Attribution-NonCommercial 4.0 International