Bempedoic Acid TBM BE study in SBOA [BE/BA News]

posted by dshah  – India/United Kingdom, 2022-03-30 17:09 (58 d 01:14 ago) – Posting: # 22889
Views: 411

(edited by dshah on 2022-03-31 11:42)

Hello All!

I was going through SBOA of Bempedoic acid marketed as Nexleton tablets.
In general, a BE study of Phase III vs TBM formulation can suffice the need for clinical significance. But in what condition, FDA can waive such condition of BE of TBM formulation with Phase III formulations in IND filing? [image]
or considering the biopharmaceutics risk assessment- it is a low risk and study can be waived?
[image]
Regards,
Divyen Shah

Complete thread:

UA Flag
Activity
 Admin contact
22,108 posts in 4,630 threads, 1,567 registered users;
online 9 (0 registered, 9 guests [including 2 identified bots]).
Forum time: Friday 18:23 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5