Bioequivalence and Bioavailability Forum

Dear Maurice,

just came across this presentation from CDER's Forum for International Drug Regulatory Authorities (April 14 - 18, 2008):

P Chandaroy and K Dhariwal
Bioequivalence Testing in the U.S. for Generic Drug Products
Division of Bioequivalence, OGD, CDER, FDA (16 April 2008)
online resource

• Meal should contain at least 50% of kcal from
  fat and provide 800-1000 kcal in total
  
• FDA publishes a standardized meal
  description
  • Non-standardized meal is acceptable if meets
    total kcal and fat kcal criteria
    
  • FDA discourages using vegetarian meals - may not
    produce same effects as non-vegetarian meals

Practically all protocols I've seen in the last 15+ years or so, exclude vegetarians anyhow. This may not be a real problem if running a study in North America or Europe (besides the terrible amount of food), but may become an issue if performing a study in an Indian CRO (see this thread).