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Statistical issues in first-in-human studies on BIA 10-2474: neglected comparison of protocol against practice
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dc.contributor.author | Bird, Sheila M. | |
dc.contributor.author | Bailey, Rosemary A. | |
dc.contributor.author | Grieve, Andrew P. | |
dc.contributor.author | Senn, Stephen | |
dc.date.accessioned | 2018-02-17T00:33:02Z | |
dc.date.available | 2018-02-17T00:33:02Z | |
dc.date.issued | 2017-03-15 | |
dc.identifier | 248865261 | |
dc.identifier | c7ae25c2-07b9-4d53-bea7-473defad7252 | |
dc.identifier | 85013302167 | |
dc.identifier | 000398057100001 | |
dc.identifier.citation | Bird , 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.1801 | en |
dc.identifier.issn | 1539-1604 | |
dc.identifier.other | ORCID: /0000-0002-8990-2099/work/39600087 | |
dc.identifier.uri | https://hdl.handle.net/10023/12740 | |
dc.description | Funding information: European Union's FP7 programme, Grant/Award Number: 602552 | en |
dc.description.abstract | By 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.extent | 7 | |
dc.format.extent | 163079 | |
dc.language.iso | eng | |
dc.relation.ispartof | Pharmaceutical Statistics | en |
dc.subject | BIAL 10-2474 | en |
dc.subject | Protocol | en |
dc.subject | Design | en |
dc.subject | Statistical issues | en |
dc.subject | Combined approvals | en |
dc.subject | HA Statistics | en |
dc.subject | QA Mathematics | en |
dc.subject | RS Pharmacy and materia medica | en |
dc.subject | T-NDAS | en |
dc.subject | SDG 3 - Good Health and Well-being | en |
dc.subject.lcc | HA | en |
dc.subject.lcc | QA | en |
dc.subject.lcc | RS | en |
dc.title | Statistical issues in first-in-human studies on BIA 10-2474: neglected comparison of protocol against practice | en |
dc.type | Journal article | en |
dc.contributor.institution | University of St Andrews. Statistics | en |
dc.contributor.institution | University of St Andrews. Centre for Interdisciplinary Research in Computational Algebra | en |
dc.identifier.doi | https://doi.org/10.1002/pst.1801 | |
dc.description.status | Peer reviewed | en |
dc.date.embargoedUntil | 2018-02-16 |
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