Bioequivalence and Bioavailability Forum

Dear Dr. Dan

❝ Applying for a BCS class biowaiver how can I demonstrate that the difference in quantitive and/or qualitative composition of my test product with regards to the the reference product does not:

❝ modulate/alter permeability of the drug

❝ influence intestinal residence time

❝ alter GI motility and permeability

❝ alter PK absorption profile

❝ without performing respective in vivo or in vitro tests?

How about doing a quick literature search?

There are many published literature available about impact of excipient on bioavailability (see this), permeability, GIT residence time and so on.

The examples what I mentioned was just to give you an idea, you can look for impact of specific ingredient/excipient in a similar way.


Hope this will help.