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Registersteady-state in patients [Design Issues]
Hi Helmut,
Recently a paper1 is published which shows Novonordisk conducted steady state study to prove BE between different strengths (3 mg, 7 mg , 14 mg vs 1.5 mg, 4 mg, 9 mg) of semaglutide tablets and EMA accepted it. As a generic company can we use the same approach for EMA?
Regards,
QA
1 https://link.springer.com/article/10.1007/s13300-024-01674-8
Recently a paper1 is published which shows Novonordisk conducted steady state study to prove BE between different strengths (3 mg, 7 mg , 14 mg vs 1.5 mg, 4 mg, 9 mg) of semaglutide tablets and EMA accepted it. As a generic company can we use the same approach for EMA?
Regards,
QA
1 https://link.springer.com/article/10.1007/s13300-024-01674-8
Complete thread:
- Do regulatory agencies accept steady-state equivalence studies? libaiyi 2024-12-04 08:34
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- HVD(P)s: steady state = history Helmut 2024-12-04 09:37
- HVD(P)s: steady state = history libaiyi 2024-12-04 09:52
- HVD(P)s: steady state = history dshah 2024-12-05 07:22
- HVD(P)s: steady state = history libaiyi 2024-12-04 09:52
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- steady-state in patients Helmut 2024-12-17 09:45
- HVD(P)s: steady state = history Helmut 2024-12-04 09:37
Ing. Helmut Schütz