Irregular profile [Outliers]

posted by drgunasakaran1  – 2013-05-07 08:33 (3978 d 05:14 ago) – Posting: # 10549
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Dear Dr Sridevi,

❝ 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.

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