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    政大機構典藏 > 商學院 > 統計學系 > 期刊論文 >  Item 140.119/79670
    Please use this identifier to cite or link to this item: http://nccur.lib.nccu.edu.tw/handle/140.119/79670


    Title: On the Assessment of Similarity of Drug Dissolution Profiles—A Simulation Study
    Authors: Ju, Huey Lin
    Contributors: 統計學系
    Keywords: Dissolution;Bioequivalence;ANOVA;Split-plot;Time series
    Date: 1997-10
    Issue Date: 2015-12-15 18:12:47 (UTC+8)
    Abstract: In vitro dissolution has been recognized as an important element in drug development to assure the quality of drug products. It determines the rate and extent of the drug release and could be used as a surrogate for bioequivalence (BE) trials under certain conditions. Although methods for assessing the similarity of dissolution profiles between two drug products are available in the literature, most of them do not provide strong statistical and/or scientific justifications. This paper examines the properties of some commonly used methods and compares the results via a simulation study under the situations where the dissolution profile can be approximated by a linear or quadratic relationship over time. The similarity factor stated in the United States Food and Drug Administration (FDA) guideline (1) and the time series approach proposed by Chow (2) are also included. The results show that Chow's method is very sensitive to the variation in the amount dissolved. Both methods are more relaxed and have a lower probability of declaring dissimilarity than the others.
    Relation: Therapeutic Innovation & Regulatory, vol. 31 no. 4, 1273-1289
    Data Type: article
    DOI 連結: http://dx.doi.org/10.1177/009286159703100427
    DOI: 10.1177/009286159703100427
    Appears in Collections:[統計學系] 期刊論文

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