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

posted by dshah  – India, 2022-03-30 19:09 (1193 d 07:33 ago) – Posting: # 22889
Views: 4,190
(edited 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
23,427 posts in 4,929 threads, 1,677 registered users;
28 visitors (0 registered, 28 guests [including 12 identified bots]).
Forum time: 02:42 CEST (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy.    Niklaus Wirth

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