Bioequivalence and Bioavailability Forum • HVDs covered by the new EU NfG

HVDs covered by the new EU NfG [BE/BA News]

posted by Helmut – Vienna, Austria, 2007-11-02 20:57 (6414 d 00:24 ago) – Posting: # 1269
Views: 8,477

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. :sleeping:

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Concept Paper for Addendum to EU NfG: HVDs Helmut 2006-05-25 13:33 [BE/BA News]
- Concept Paper for Addendum to EU NfG: HVDs joyjac 2006-10-03 06:03
  - HVDs covered by the new EU NfGHelmut 2007-11-02 19:57