Irregular profile [Outliers]

posted by Dr sridevi – India, 2013-05-06 15:24 (3683 d 06:13 ago) – Posting: # 10547
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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]

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