Bioequivalence and Bioavailability Forum

Dear Jaime!

Funny enough at last year’s Regulatory Workshop on BE/Dissolution I asked Vinod Shah:

• Were there any ANDAs approved based on a clinical equivalence study?
  
• If yes, how many subjects were involved?

The answer was:

• No! (within the 30 years Vinod was with the FDA)

Consequently – although mentioned in many guidelines – I would consider clinical equivalence studies a rather hypothetical option.

Dear Jaime,

Since this is an off topic, I would be bold to add few lines here. Clinical equivalence are those studies in my opinion where there is a need to see pharmacodynamic end points rather than concentrations in blood. Examples are meter-dose inhalers (MDIs). There are canadian and other guidelines how to conduct studies for approval of generic MDIs. Some studies we have conducted on MDIs involved the measurement of FEV1 activity in mild to moderate asthmatic patients. There may be few more expamles on this list.

Dr. Shiv

Edit: Full quote removed. [HS]