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Regulatory Perspective on Drug Safety Assessment during Drug Development

  • In: Symposium A4: Systems pharmacology –innovative approaches to drug safety on Wednesday, 24 May 2017, 09:10-09:35
  • At: Stockholm (Sweden) (2017)
  • 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 28 September 2023

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