Bridging Study Evaluation
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Bridging Study Evaluation - The Three-year Experience in Taiwan Center for Drug Evaluation Yi-jin Chiou, Ph.D. October 28, 2003 PowerPoint PPT Presentation


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Bridging Study Evaluation - The Three-year Experience in Taiwan Center for Drug Evaluation Yi-jin Chiou, Ph.D. October 28, 2003. Regulatory Reform in Clinical Trials.

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Bridging Study Evaluation - The Three-year Experience in Taiwan Center for Drug Evaluation Yi-jin Chiou, Ph.D. October 28, 2003

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Bridging study evaluation the three year experience in taiwan center for drug evaluation yi jin

Bridging Study Evaluation

- The Three-year Experience in Taiwan

Center for Drug Evaluation

Yi-jin Chiou, Ph.D.

October 28, 2003


Regulatory reform in clinical trials

Regulatory Reform in Clinical Trials

  • July 7 Announcement (1993): An approved study report of a local clinical trial is required for the new drug application in Taiwan

  • Double 12 Announcement (2000): Bridging Studies

    *2001: BSE optional; BS optional if not waived

    *2003: BSE mandatory; BS optional if not waived

    *2004: BSE mandatory; BS only if not waived


Bridging study evaluation the three year experience in taiwan center for drug evaluation yi jin

Current Checklist for Assessing Ethnic Sensitivity


Bridging study evaluation the three year experience in taiwan center for drug evaluation yi jin

Results for BS Evaluation (I)(01/2001-8/2003)

  • Application-74 cases

Asian data

33 (53%)

  • Case evaluated

    (62)

29 (47%)

No Asian data

Asian data

26 (79%)

  • BS waived

    (49)(79%)

23 (79%)

No Asian data


Bridging study evaluation the three year experience in taiwan center for drug evaluation yi jin

 13 cases-bridging study not waived (21 %)

★ Concerns of drug-drug interactions; ★ Concerns of dose adjustment


Bridging study evaluation the three year experience in taiwan center for drug evaluation yi jin

 13 cases-bridging study not waived (21 %)


Bridging study evaluation the three year experience in taiwan center for drug evaluation yi jin

Recommended Checklist for Assessing Ethinic Sensitivity

<Ref> Lin et al. DIA 37: 143-145, 155-158, 2003


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