國家衛生研究院 NHRI:Item 3990099045/1776
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/1776


    Title: On difference factor in assessment of dissolution similarity
    Authors: Liu, JP;Ma, MC
    Contributors: Division of Biostatistics and Bioinformatics
    Abstract: In vitro dissolution similarity has been suggested as a surrogate for assessing equivalence between the pre-changed and post-changed formulations for postapproval changes of a drug. The difference factor f(1), based on the absolute mean difference, has been proposed as a criterion for evaluating similarity between dissolution profiles. Statistical properties including density function, bias, and asymptotic distribution of a consistent estimator are investigated. Due to complexity of the distribution of the estimator, we suggest the use of the confidence intervals obtained from the bootstrap method for evaluation of dissolution similarity. A simulation was conducted to examine the size and power of the proposed CI procedure. Comparisons with other criteria such as similarity factor are also provided. Numerical examples are used to illustrate the proposed CI procedure.
    Keywords: Statistics & Probability
    Date: 2000
    Relation: Communications in Statistics: Theory and Methods. 2000;29(5-6):1089-1113.
    Link to: http://dx.doi.org/10.1080/03610920008832533
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0361-0926&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000086727400012
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=26844561710
    Appears in Collections:[Jen-Pei Liu(1998-2002)] Periodical Articles

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