PE outside the acceptance range [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2015-07-27 14:36 (3482 d 19:41 ago) – Posting: # 15154
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Hi Aan,

❝ As per the regulatory requirements and guidelines for modified release tablet both fasting and fed study is recommended (MHRA, USFDA etc).


Exactly. BTW, MHRA follows EMA’s GLs.

❝ Regulatory agency - MHRA UK, canada, MOH UAE. will they accept the study if fasting meets the criteria and the fed study fails.


Why should they (i.e., ignoring their own rules)?
Esomeprazole exhibits a pronounced food effect (reduced BA). Although dosing in the fasted state is recommended in the innovator product’s label/SmPC in a generic application you have to show BE for both fasting/fed conditions. I don’t know on which side your product failed (upper = less food effect or lower = higher food effect). Even in the former case, the test product is not similar to the reference, but “better”. In some legislations you could opt for a “hybrid application” which would require an additional clinical study.

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