國家衛生研究院 NHRI:Item 3990099045/1788
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/1788


    Title: Rethinking statistical approaches to evaluating drug safety
    Authors: Liu, JP
    Contributors: Division of Biostatistics and Bioinformatics
    Abstract: The current methods used to evaluate the efficacy of drug products are inadequate. We propose a non-inferiority approach to prove the safety of drugs. Materials and Methods: Traditional hypotheses for the evaluation of the safety of drugs are based on proof of hazard, which have proven to be inadequate. Therefore, based on the concept of proof of safety, the non-inferiority hypothesis is employed to prove that the risk of new drugs does not exceed a pre-specified allowable safety margin, hence proving that a drug has no excessive risk. The results from papers published on Vioxx (R) and Avandia (R) are used to illustrate the difference between the traditional approach for proof of hazard and the non-inferiority approach for proof of safety. Results: The p-values from traditional hypotheses were greater than 0.05, and failed to demonstrate that Vioxx (R) and Avandia (R) are of cardiovascular hazard. However, these results cannot prove that both Vioxx (R) and Avandia (R) are of no cardiovascular risk. On the other hand, the non-inferiority approach can prove that they are of excessive cardiovascular risk. Conclusion: The non-inferiority approach is appropriate to prove the safety of drugs.
    Keywords: Medicine, General & Internal
    Date: 2007-12-31
    Relation: Yonsei Medical Journal. 2007 Dec;48(6):895-900.
    Link to: http://dx.doi.org/10.3349/ymj.2007.48.6.895
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0513-5796&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000252239900001
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=38049148618
    Appears in Collections:[Jen-Pei Liu(1998-2002)] Periodical Articles

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