Bioequivalence and Bioavailability Forum

❝ Is it required to compare against the reference product? If so, is it based on f2?

yes. If you go to FDA's guidance page looking for new individual BE guidance for MR product, almost all of them require this test and:

"Both test and reference listed drug (RLD) products should be tested accordingly and data should be provided on individual unit, means, range and %CV on all strengths."

❝ If the rate of in-vitro release in EtOH is not similar (i.e., faster but not the point of dose dumping) to that of the reference, then what?

check this link.

http://www.aapsj.org/abstracts/am_2008/aaps2008-001832.pdf

I hope this helps.

Shuanghe