Low AUC after reference product [Study As­sess­ment]

posted by mittyri – Russia, 2018-03-15 10:56  – Posting: # 18550
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Hi Helmut,

» Correct – if you didn’t state such a possible reason for exclusion it in the protocol.

If 5% GMR for ref is not mentioned in the Protocol isn't possible just to refer to EMA or other appropriate GL (depending on the jurisdiction)?

Have you ever seen lucky guys in EMA jurisdiction who stated in the protocol some additional reasons for exclusion (not mentioned in GL) after ending the bioanalytical part and successfully applied them in borderline case like that?

Kind regards,
Mittyri

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