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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 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:
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