(436 d 00:43 ago)
(edited by dshah on 2022-03-31 11:42)
Posting: # 22889
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?
or considering the biopharmaceutics risk assessment- it is a low risk and study can be waived?
(435 d 09:09 ago)
Posting: # 22890
I heard from a change in the shape of the tablet will raise question as well.