Regulatory perspective on use of foreign clinical data for drug approval: pmda

• In: SYMPOSIUM: CROSSING THE BRIDGE on Wednesday, 16 April 2014, 13:00-14:30
• At: PSWC, Melbourne (Australia) (2014)
• Type: Presentation
• By: UYAMA, Yoshiaki (Pharmaceuticals and Medical Devices Agency, Office of Review Management, Tokyo, Japan)
• Abstract:

  Since ICH E5 guideline was implemented in 1998, use of foreign clinical data in newdrug application has been significantly increased. For extrapolating foreignclinical data into the new region successfully, impacts of ethnic factors indrug responses should be carefully considered in advance. In our experience, PKand dose-response relationships are

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