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Current status of bridging studies in Asia

  • In: D3 - The challenge of ethnic differences in drug response for drug development and regulation on Tuesday, 2 September 2014, 9:00-12:00
  • At: Bangkok (Thailand) (2014)
  • Type: Presentation
  • By: HU, Yoa-Pu (National Defense Medical Center, School of Pharmacy, Taipei, China Taiwan)
  • Abstract:

    There are a number of countries that require local clinical trials for registration as a pre-requisite for marketing the drug in the country, such as China and India, as well as countries that require bridging studies (BS), such as Japan, South Korea and Taiwan. It has now been over 10 years since the ICH E5 Guideline was signed off under the


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Last update 28 September 2023

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