國家衛生研究院 NHRI:Item 3990099045/1785
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/1785


    Title: An alternative approach to evaluation of poolability for stability studies
    Authors: Liu, JP;Tung, SC;Pong, YM
    Contributors: Division of Biostatistics and Bioinformatics
    Abstract: The current method for pooling the data from different batches or factors, suggested by ICH Q1E guidance, is to use analysis of covariance (ANCOVA) for test interaction between slopes and intercepts and factors. Failure to reject the null hypothesis of equality of slopes and equality of intercepts, however, does not prove that slopes and intercepts from different levels of factors are the same, and the data can be pooled for estimation of shelf life. In addition, the ANCOVA approach uses indirect parameters of intercepts and slopes in the regression model for assessment of poolability. The hypothesis for poolability is then formulated on the basis of the concept of equivalence for the means among the distributions of the quantitative attributes at a particular time point. Methods based on the intersection-union procedure are proposed to test the hypothesis of equivalence. A large simulation study was conducted to empirically investigate the size and power of the proposed method for the bracketing and matrixing designs given in the ICH QID guidance. Simulation results show that the proposed method can adequately control the size and provides sufficient power when the number of factors considered is fewer than three. A numerical example using the published data illustrates the proposed method.
    Keywords: Pharmacology & Pharmacy;Statistics & Probability
    Date: 2006-01
    Relation: Journal of Biopharmaceutical Statistics. 2006 Jan;16(1):1-14.
    Link to: http://dx.doi.org/10.1080/10543400500406421
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1054-3406&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000236233500001
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=30344439794
    Appears in Collections:[Jen-Pei Liu(1998-2002)] Periodical Articles

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