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RegisterBempedoic 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]](img/uploaded/image236.jpg)
or considering the biopharmaceutics risk assessment- it is a low risk and study can be waived?
![[image]](img/uploaded/image237.jpg)
Regards,
Divyen Shah
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?
Regards,
Divyen Shah
Complete thread:
- Bempedoic Acid TBM BE study in SBOAdshah 2022-03-30 17:09
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- Bempedoic Acid TBM BE study in SBOA jag009 2022-03-31 08:43
Ing. Helmut Schütz