Development of Triptans in Japan: Bridging Strategy Based on the ICH-E5 Guideline

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  • Shimazawa Rumiko
    Faculty of Pharmaceutical Science, Doshisha Women's College of Liberal Arts
  • Ando Yuki
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Hidaka Shinji
    Faculty of Pharmaceutical Sciences at Kagawa Campus, Tokushima Bunri University
  • Saito Kazuyuki
    Faculty of Pharmaceutical Science, Hokuriku University
  • Toyoshima Satoshi
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Kobayashi Fumiaki
    Center for Clinical Trials, Japan Medical Association, Bunkyo Green Court Center Office

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In Japan, five new drug applications (NDAs) of triptans have been approved through a bridging strategy. They constituted the largest target disease field among 26 NDAs which had been approved through the strategy between 1999 and 2003. The bridging strategies of the drugs were classified into two major categories to be described below. One was to conduct a placebo-controlled dose-response study as a bridging study in an attempt to extrapolate the data from the pivotal foreign Phase III studies including a repeated dose study (i.e., zolmitriptan, sumatriptan succinate, and eletriptan hydrobromide). Another was to conduct a placebo-controlled Phase III study in Japan in an attempt to extrapolate the data for efficacy from a repeated dose study (i.e., sumatriptan and rizatriptan benzoate). The extrinsic ethnic factors relating to triptans did not interfere with the extrapolation of foreign clinical data in the five applications. A bridging strategy reduced the number of clinical trials and/or sample size. The accumulation of these bridging experiences indicated that foreign clinical data could be used to support the approval of triptans in Japan. <br>

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