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http://hdl.handle.net/1942/42530
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DC Field | Value | Language |
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dc.contributor.author | MEYVISCH, Paul | - |
dc.contributor.author | Ebrahimpoor, Mitra | - |
dc.date.accessioned | 2024-03-05T09:47:08Z | - |
dc.date.available | 2024-03-05T09:47:08Z | - |
dc.date.issued | 2024 | - |
dc.date.submitted | 2024-03-05T09:39:13Z | - |
dc.identifier.citation | PHARMACEUTICAL STATISTICS, | - |
dc.identifier.issn | 1539-1604 | - |
dc.identifier.uri | http://hdl.handle.net/1942/42530 | - |
dc.description.abstract | Drug-drug interaction (DDI) trials are an important part of drug development as they provide evidence on the benefits and risks when two or more drugs are taken concomitantly. Sample size calculation is typically recommended to be based on the existence of clinically justified no-effect boundaries but these are challenging to define in practice, while the default no-effect boundaries of 0.8-1.25 are known to be overly conservative requiring a large sample size. In addition, no-effect boundaries are of little use when there is prior pharmacological evidence that a mild or moderate interaction between two drugs may be present, in which case effect boundaries would be more useful. We introduce precision-based sample size calculation that accounts for both the stochastic nature of the pharmacokinetic parameters and the anticipated width of (no-)effect boundaries, should these exist. The methodology is straightforward, requires considerably less sample size and has favorable operating characteristics. A case study on statins is presented to illustrate the ideas. | - |
dc.description.sponsorship | The authors would like to thank the editor and the anonymous reviewers for their meticulous review and valuable comments. We also wish to thank Dr. Andy Grieve for providing input to the historical notes on precision-based sample size calculation. | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.rights | 2024 John Wiley & Sons Ltd. | - |
dc.subject.other | drug interaction | - |
dc.subject.other | precision | - |
dc.title | On sample size calculation in drug interaction trials | - |
dc.type | Journal Contribution | - |
local.format.pages | 10 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | Meyvisch, P (corresponding author), Univ Hasselt, I BioStat, Agoralaan, B-3590 Diepenbeek, Belgium. | - |
dc.description.notes | paul.meyvisch@hotmail.com | - |
local.publisher.place | 111 RIVER ST, HOBOKEN 07030-5774, NJ USA | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
local.bibliographicCitation.status | Early view | - |
dc.identifier.doi | 10.1002/pst.2367 | - |
dc.identifier.pmid | 38356204 | - |
dc.identifier.isi | 001162065200001 | - |
dc.identifier.eissn | 1539-1612 | - |
dc.identifier.eissn | 1539-1612 | - |
local.provider.type | wosris | - |
local.description.affiliation | [Meyvisch, Paul] Univ Hasselt, I BioStat, Agoralaan, B-3590 Diepenbeek, Belgium. | - |
local.description.affiliation | [Ebrahimpoor, Mitra] Leiden Univ, Med Ctr, Biomed Data Sci, Leiden, Netherlands. | - |
local.uhasselt.international | yes | - |
item.fullcitation | MEYVISCH, Paul & Ebrahimpoor, Mitra (2024) On sample size calculation in drug interaction trials. In: PHARMACEUTICAL STATISTICS,. | - |
item.fulltext | With Fulltext | - |
item.contributor | MEYVISCH, Paul | - |
item.contributor | Ebrahimpoor, Mitra | - |
item.accessRights | Restricted Access | - |
crisitem.journal.issn | 1539-1604 | - |
crisitem.journal.eissn | 1539-1612 | - |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
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Pharmaceutical Statistics - 2024 - Meyvisch - On sample size calculation in drug interaction trials.pdf Restricted Access | Early view | 734.46 kB | Adobe PDF | View/Open Request a copy |
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