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dc.contributor.authorBird, Sheila M.
dc.contributor.authorBailey, Rosemary A.
dc.contributor.authorGrieve, Andrew P.
dc.contributor.authorSenn, Stephen
dc.date.accessioned2018-02-17T00:33:02Z
dc.date.available2018-02-17T00:33:02Z
dc.date.issued2017-03-15
dc.identifier.citationBird , S M , Bailey , R A , Grieve , A P & Senn , S 2017 , ' Statistical issues in first-in-human studies on BIA 10-2474: neglected comparison of protocol against practice ' Pharmaceutical Statistics , vol. 16 , no. 2 , pp. 100-106 . https://doi.org/10.1002/pst.1801en
dc.identifier.issn1539-1604
dc.identifier.otherPURE: 248865261
dc.identifier.otherPURE UUID: c7ae25c2-07b9-4d53-bea7-473defad7252
dc.identifier.otherScopus: 85013302167
dc.identifier.otherORCID: /0000-0002-8990-2099/work/39600087
dc.identifier.otherWOS: 000398057100001
dc.identifier.urihttp://hdl.handle.net/10023/12740
dc.descriptionFunding information: European Union's FP7 programme, Grant/Award Number: 602552en
dc.description.abstractBy setting the regulatory-approved protocol for a suite of first-in-human studies on BIA 10-2474 against the subsequent French investigations, we highlight six key design and statistical issues which reinforce recommendations by a Royal Statistical Society Working Party which were made in the aftermath of cytokine release storm in six healthy volunteers in the UK in 2006. The 6 issues are dose determination, availability of pharmacokinetic results, dosing interval, stopping rules, appraisal by safety committee, and clear algorithm required if combining approvals for single and multiple ascending dose studies.
dc.format.extent7
dc.language.isoeng
dc.relation.ispartofPharmaceutical Statisticsen
dc.rightsCopyright © 2017 John Wiley & Sons, Ltd. This work has been made available online in accordance with the publisher’s policies. This is the author created, accepted version manuscript following peer review and may differ slightly from the final published version. The final published version of this work is available at: https://doi.org/10.1002/pst.1801en
dc.subjectBIAL 10-2474en
dc.subjectProtocolen
dc.subjectDesignen
dc.subjectStatistical issuesen
dc.subjectCombined approvalsen
dc.subjectHA Statisticsen
dc.subjectQA Mathematicsen
dc.subjectRS Pharmacy and materia medicaen
dc.subjectT-NDASen
dc.subject.lccHAen
dc.subject.lccQAen
dc.subject.lccRSen
dc.titleStatistical issues in first-in-human studies on BIA 10-2474: neglected comparison of protocol against practiceen
dc.typeJournal articleen
dc.description.versionPostprinten
dc.contributor.institutionUniversity of St Andrews.Statisticsen
dc.contributor.institutionUniversity of St Andrews.Centre for Interdisciplinary Research in Computational Algebraen
dc.identifier.doihttps://doi.org/10.1002/pst.1801
dc.description.statusPeer revieweden
dc.date.embargoedUntil2018-02-16


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