Log in
RegisterIrregular profile [Outliers]
Dear Dr Sridevi,
As per the Scientific Literature, Tmax of Omeprazole may occur at 10.00 hours also under fed conditions.
Reference: Public Assessment Report, Scientific discussion, Omeprazol Copyfarm” Omeprazole, DK/H/1650/001-003/MR
Regulatory may not accept exclusion of subject based on Pharmacokientic profile especially for delayed release test formulation.
❝ Molecule: Delayed release omeprazole, Concentration appearing only in elimination phase. (after 10 hrs)
As per the Scientific Literature, Tmax of Omeprazole may occur at 10.00 hours also under fed conditions.
Reference: Public Assessment Report, Scientific discussion, Omeprazol Copyfarm” Omeprazole, DK/H/1650/001-003/MR
❝ We are planned to submit the data with and without that particular subject.
Regulatory may not accept exclusion of subject based on Pharmacokientic profile especially for delayed release test formulation.
—
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Complete thread:
- Irregular profile Dr sridevi 2013-05-06 13:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Irregular profile Dr_Dan 2013-05-06 14:05
- Irregular profiledrgunasakaran1 2013-05-07 06:33
Ing. Helmut Schütz