Bioequivalence and Bioavailability Forum • Bempedoic Acid TBM BE study in SBOA

dshah
★★

India,
2022-03-30 19:09
(1138 d 17:00 ago)

(edited on 2022-03-31 11:42)
Posting: # 22889
Views: 3,657

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

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 (1138 d 01:26 ago) @ dshah Posting: # 22890 Views: 2,988	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