dshah
★★  

India,
2022-03-30 19:09
(1545 d 08:05 ago)

(edited on 2022-03-31 11:42)
Posting: # 22889
Views: 5,966
 

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

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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
(1544 d 16:31 ago)

@ dshah
Posting: # 22890
Views: 4,826
 

 Bempedoic Acid TBM BE study in SBOA

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Hi,
I heard from a change in the shape of the tablet will raise question as well.
J
 
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