dshah
★★  

India/United Kingdom,
2022-03-30 19:09
(754 d 18:30 ago)

(edited by dshah on 2022-03-31 11:42)
Posting: # 22889
Views: 2,053
 

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

Post reply
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
 
jag009
★★★

NJ,
2022-03-31 10:43
(754 d 02:55 ago)

@ dshah
Posting: # 22890
Views: 1,730
 

 Bempedoic Acid TBM BE study in SBOA

Post reply
Hi,
I heard from a change in the shape of the tablet will raise question as well.
J
 
UA Flag
Activity
 Admin contact
22,990 posts in 4,826 threads, 1,665 registered users;
56 visitors (0 registered, 56 guests [including 2 identified bots]).
Forum time: 13:39 CEST (Europe/Vienna)

If you don’t like something change it;
if you can’t change it, change the way you think about it.    Mary Engelbreit

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