(3683 d 06:15 ago)
Posting: # 10547
Can you please guide me in the below issue ?
One of the subject behaving in different manner particularly for test product.
Molecule: Delayed release omeprazole
Concentration appearing only in elimination phase. (after 10 hrs)
Investigational report performed at all stages of clinical phase. Except this subject rest of them are normal. How to proceed further.
We are planned to submit the data with and without that particular subject. Please guide me
Edit: Subject line and category changed. [Helmut]
(3683 d 05:34 ago)
@ Dr sridevi
Posting: # 10548
Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics.
An outlier test is not an expectation of the medicines agencies but outliers could be shown by a box plot. This would allow the medicines agencies to compare the data between them. However, since it is the test product it will be hard to justify the exclusion of the subject from statistical analysis.
Kind regards and good luck
Kind regards and have a nice day
(3682 d 13:06 ago)
@ Dr sridevi
Posting: # 10549
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.