dshah
★★  

India,
2022-03-30 19:09
(1194 d 10:13 ago)

(edited on 2022-03-31 11:42)
Posting: # 22889
Views: 4,193
 

 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
(1193 d 18:38 ago)

@ dshah
Posting: # 22890
Views: 3,406
 

 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
23,427 posts in 4,929 threads, 1,680 registered users;
23 visitors (0 registered, 23 guests [including 11 identified bots]).
Forum time: 05:22 CEST (Europe/Vienna)

No matter what side of the argument you are on,
you always find people on your side
that you wish were on the other.    Thomas Berger

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