Current status of bridging studies in Asia
- At: 2014 FIP Congress in Bangkok (Thailand)
- Type: Presentation
- By: HU, Yoa-Pu (National Defense Medical Center, School of Pharmacy, Taipei, China Taiwan)
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.