Esmeprazole Gastro resistant tablet BE study [Study As­sess­ment]

posted by aanrin – United Arab Emirates, 2015-07-27 13:45 (3167 d 17:03 ago) – Posting: # 15149
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Dear Sir/Madam,

The following BE study results for Esmeprazole Gastro resistant tablet

Fed Study - The Test to Reference ratio of geometric LSmeans for the Cmax was outside the acceptance range of 80 to 125% and the corresponding 90% confidence interval was also outside the widened range of 75 to 133%. The Test to Reference ratio of geometric LSmeans for the AUCT and AUC∞ were within the acceptance range of 80 to 125%, however, their corresponding 90% confidence intervals were outside this range.

Fasting Study - meets all criterias and found to be bioequivalent.

Please advice me whether the product will be accepted as generic by the regulatory authority if the fed study fails but fasting study is succesful.

Wityh Regards

Aan


Edit: Category changed. [Helmut]

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