WHO guidelines on registration requirements to establish interchangeability

• In: S2 - Bioequivalence and BCS on Monday, 28 August 2006, 14:00-17:00
• At: Salvadore (Brazil) (2006)
• 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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