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Regulatory Perspective on Drug Safety Assessment during Drug Development

  • At: 2017 FIP Congress in Stockholm (Sweden)
  • Type: Presentation
  • By: SATO, Masanobu (Pharmaceuticals & Medical Devices Agency, Tokyo, Japan)
  • Co-author(s): Masanobu Sato: Pharmaceuticals & Medical Devices Agency, Tokyo, Japan
  • Abstract:

    One of the major concerns when conducting evaluation of a new drug at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan is whether there are any unacceptable risks as compared to the benefit.  A comprehensive evaluation on drug safety should be conducted considering whether the recognized risks in clinical studies can be controlled,

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Last update 4 October 2019

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