Bioequivalence and Bioavailability Forum

Dear Paresh!

❝ Drug having comparable dissolution data as reference drug.

Don’t mix up ‘drug’ with ‘drug product’ or ‘formulation’. I guess you compared a ‘test product’ with the ‘reference product’.

❝ Although drug fail to achieve bioequivalence criteria.

❝

❝ Can you provide reason for the same?

• Human guineapigs are nasty beasts. Don’t behave like dissolution vessels.
  
• Your dissolution method is not discriminatory enough (Have you checked that at all? Batches with different characteristics tested in pilot studies?).
  
• And many more…

Of course everybody tries to match the dissolution of the reference before going into a pivotal in vivo study, but more often than not results are different. What if permeability is the rate-limiting step? Any dissolution test will be unpredictive by definition. If IVIVC would be that easy, all CROs would cut down their business and we would see a lot more successful BCS-based biowaivers.