Bioequivalence and Bioavailability Forum

Dear Joy and all others!

❝ We are looking forward to this.

It will take some time...

During EGA’s BE workshop last week (more than 80 members of regulatory authorities were attending) some kind of a “roadmap” was presented.
HVD(P)s will be covered by the new version of the European BA/BE guideline (no separate document is to be expected). Scaled ABE is currently under discussion, but personally I would consider any application without a Scientific Advisory Meeting still a very risky business.
The drafted guideline (for comments) is expected for autumn 2008, the final version for 2008/2009.