國家衛生研究院 NHRI:Item 3990099045/4476
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    题名: Assessing bioequivalence using genomic data
    作者: Chow, S;Shao, J;Li, L
    贡献者: Division of Biostatistics and Bioinformatics
    摘要: For approval of a generic drug product, the assessment of bioequivalence in drug absorption is usually considered as a surrogate for evaluation of drug efficacy and safety in clinical studies. For some drug products, the United States Food and Drug Administration indicates that the assessment of similarity between dissolution profiles may be used as a surrogate for assessment of bioequivalence. Along this line, we propose assessing bioequivalence using genomic data collected from the same individuals, assuming that there is an established relationship between pharmacokinetic and genomic data. Because there may be a bias in the prediction of pharmacokinetic data using genomic data and the variations in these two types of data are different, we propose to assess bioequivalence based on sensitivity analysis of prediction bias and variation difference within some predetermined limits. Our methods are derived for average, population, and individual bioequivalence.
    日期: 2004-12
    關聯: Journal of Biopharmaceutical Statistics. 2004 Dec;14(4):869-880.
    Link to: http://dx.doi.org/10.1081/bip-200035420
    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=9244263007
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