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WHO guidelines on registration requirements to establish interchangeability

  • At: 2006 FIP Congress in Salvadore (Brazil)
  • Type: Presentation
  • By: MIDHA, Kamal (University of Saskatchewan Pharmalytics, Pharmacy & Nutrition, and Medicine, Saskatoon, Canada)
  • Abstract:

    This guideline makes recommendation to sponsors for the requirements of a multisource (generic) pharmaceutical product approval in their respective countries. The appropriate in vitro and in vivo requirements are discussed. It is imperative that the national health and drug regulatory authorities by which a particular product is controlled

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Last update 4 October 2019

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