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  1. Article ; Online: Correction: Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies.

    Schütz, Helmut / Burger, Divan A / Cobo, Erik / Dubins, David D / Farkás, Tibor / Labes, Detlew / Lang, Benjamin / Ocaña, Jordi / Ring, Arne / Shitova, Anastasia / Stus, Volodymyr / Tomashevskiy, Michael

    The AAPS journal

    2024  Volume 26, Issue 3, Page(s) 58

    Language English
    Publishing date 2024-05-06
    Publishing country United States
    Document type Published Erratum
    ISSN 1550-7416
    ISSN (online) 1550-7416
    DOI 10.1208/s12248-024-00927-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies.

    Schütz, Helmut / Burger, Divan A / Cobo, Erik / Dubins, David D / Farkás, Tibor / Labes, Detlew / Lang, Benjamin / Ocaña, Jordi / Ring, Arne / Shitova, Anastasia / Stus, Volodymyr / Tomashevskiy, Michael

    The AAPS journal

    2024  Volume 26, Issue 3, Page(s) 50

    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 ... ...

    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.
    MeSH term(s) Humans ; Biological Availability ; Research Design ; Cross-Over Studies
    Language English
    Publishing date 2024-04-17
    Publishing country United States
    Document type Journal Article
    ISSN 1550-7416
    ISSN (online) 1550-7416
    DOI 10.1208/s12248-024-00921-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

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    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

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