Marginally failed study for Europe [Study As­sess­ment]

posted by balakotu – India, 2018-04-24 07:30 (1576 d 10:35 ago) – Posting: # 18726
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Hi,
I have conducted a full replicate BE study for one of the highly variable product for Europe regulatory.
Based on the reference product variability, relaxed 90% Confidence Intervals is 75.18 to 133.01 for Cmax.
Study marginally failed with 90% upper CI data of 133.18
Is there any way to justify Europe regulatory authority(ies) to accept this study data? (DCP submission)

Regards


Edit: Category changed; see also this post #1 and #4. [Helmut]

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