PE outside the acceptance range [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2015-07-27 14:22 (3487 d 16:21 ago) – Posting: # 15152
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Hi Aan,

as mentioned above, please tell us the regulatory agency you want to submit the studies.

❝ But the fasting study meets all the criteria. only fed study fails.


❝ So please let me know for Modified release products both fasting and fed study should be successful?


Counterquestion: Why did you perform studies in both fasting and fed conditions?

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