Challenges in the development and registration of problematic generic products

• In: S1 - Biopharmaceutics and drug development process on Monday, 5 September 2005, 9:00-17:00
• At: Cairo (Egypt) (2005)
• Type: Presentation
• By: MIDHA, Kamal (Pharmalytics Inc., University of Saskatchewan, Saskatoon, SK, Canada)
• Co-author(s): Hubbard (Pharmalytics Inc., Saskatoon, SK, Canada)
  Patnaik (Watson Laboratories, Corona, CA, United States of America)
  Shah, Vinod (Food and Drug Administration, Rockville, United States of America)
  
• Abstract:

  We discuss unresolved issues in the registration of multisource products and make sug-gestions for their resolution. Two products are therapeutically equivalent if, after the same molar dose, they show similar safety and efficacy profiles. The products must be Pharmaceutically Equivalent or Pharmaceutically Alternatives. Pharmaceutical

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