Log in
RegisterMultiple dose studies waived based on single dose studies [Regulatives / Guidelines]
Dear Mr Rana,
If your X molecule is a Prolonged Release Formulation meant for EMA submission, then you need to conduct Steady State Study also. You cannot waive the Steady state study based on Fasting and Fed studies results in case of Prolonged Release formulation.
If your X molecule is a Prolonged Release Formulation meant for EMA submission, then you need to conduct Steady State Study also. You cannot waive the Steady state study based on Fasting and Fed studies results in case of Prolonged Release formulation.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Multiple dose studies waived based on single dose studies rana 2012-09-14 11:32
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Multiple dose studies waived based on single dose studiesdrgunasakaran1 2012-09-14 13:09
- MD waiving based on SD 90–111% CI unlikely Helmut 2012-09-14 14:05
Ing. Helmut Schütz