國家衛生研究院 NHRI:Item 3990099045/1776
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    題名: On difference factor in assessment of dissolution similarity
    作者: Liu, JP;Ma, MC
    貢獻者: Division of Biostatistics and Bioinformatics
    摘要: 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.
    關鍵詞: Statistics & Probability
    日期: 2000
    關聯: 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
    顯示於類別:[劉仁沛(1998-2002)] 期刊論文

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