dc.contributor.author |
Schuetz, Helmut
|
|
dc.contributor.author |
Burger, Divan Aristo
|
|
dc.contributor.author |
Cobo, Erik
|
|
dc.contributor.author |
Dubins, David D.
|
|
dc.contributor.author |
Farkas, Tibor
|
|
dc.contributor.author |
Labes, Detlew
|
|
dc.contributor.author |
Lang, Benjamin
|
|
dc.contributor.author |
Ocana, Jordi
|
|
dc.contributor.author |
Ring, Arne
|
|
dc.contributor.author |
Shitova, Anastasia
|
|
dc.contributor.author |
Stus, Volodymyr
|
|
dc.contributor.author |
Tomashevskiy, Michael
|
|
dc.date.accessioned |
2024-05-21T05:40:06Z |
|
dc.date.available |
2024-05-21T05:40:06Z |
|
dc.date.issued |
2024-04 |
|
dc.description.abstract |
Comparative bioavailability studies often involve multiple groups of subjects for a variety of reasons, such as clinical capacity limitations. This raises questions about the validity of pooling data from these groups in the statistical analysis and whether a group-by-treatment interaction should be evaluated. We investigated the presence or absence of group-by-treatment interactions through both simulation techniques and a meta-study of well-controlled trials. Our findings reveal that the test falsely detects an interaction when no true group-by-treatment interaction exists. Conversely, when a true group-by-treatment interaction does exist, it often goes undetected. In our meta-study, the detected group-by-treatment interactions were observed at approximately the level of the test and, thus, can be considered false positives. Testing for a group-by-treatment interaction is both misleading and uninformative. It often falsely identifies an interaction when none exists and fails to detect a real one. This occurs because the test is performed between subjects in crossover designs, and studies are powered to compare treatments within subjects. This work demonstrates a lack of utility for including a group-by-treatment interaction in the model when assessing single-site comparative bioavailability studies, and the clinical trial study structure is divided into groups. |
en_US |
dc.description.department |
Statistics |
en_US |
dc.description.librarian |
hj2024 |
en_US |
dc.description.sdg |
None |
en_US |
dc.description.sponsorship |
Open access funding provided by Medical University of Vienna. |
en_US |
dc.description.uri |
https://link.springer.com/journal/12248 |
en_US |
dc.identifier.citation |
Schütz, H., Burger, D.A., Cobo, E. et al. Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies. The AAPS Journal 26, 50 (2024). https://doi.org/10.1208/s12248-024-00921-x. |
en_US |
dc.identifier.issn |
1550-7416 |
|
dc.identifier.other |
10.1208/s12248-024-00921-x |
|
dc.identifier.uri |
http://hdl.handle.net/2263/96098 |
|
dc.language.iso |
en |
en_US |
dc.publisher |
Springer |
en_US |
dc.rights |
© The Author(s) 2024, corrected publication 2024. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License. |
en_US |
dc.subject |
Average bioequivalence |
en_US |
dc.subject |
Group-by-treatment interaction |
en_US |
dc.subject |
Monte-Carlo simulations |
en_US |
dc.subject |
Regulatory guidelines |
en_US |
dc.title |
Group-by-treatment interaction effects in comparative bioavailability studies |
en_US |
dc.type |
Article |
en_US |