國家衛生研究院 NHRI:Item 3990099045/4515
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    題名: Assessment of similarity between dissolution profiles
    作者: Ma, M;Wang, B;Liu, J;Tsong, Y
    貢獻者: Division of Biostatistics and Bioinformatics
    摘要: In vitro dissolution equivalence has been assessed through profile comparison between the test and reference formulations for postapproval changes. Functions of the absolute mean difference and average squared mean differences were two of the often-used criteria to evaluate distance or similarity between general profiles. The two functions and their methods of moment estimators are studied in this paper as an application to similarity assessment of two dissolution profile. Due to the complexity of the distributions of these estimators, the confidence intervals obtained from the bootstrap method were used for testing the hypothesis of dissolution similarity. The size and power of two procedures are examined with a simulation study. A numerical example is used to illustrate the application of the procedures.
    日期: 2000
    關聯: Journal of Biopharmaceutical Statistics. 2000;10(2):229-249.
    Link to: http://dx.doi.org/10.1081/bip-100101024
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1054-3406&DestApp=IC2JCR
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=0033823162
    顯示於類別:[劉仁沛(1998-2002)] 期刊論文

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