Use of 96.7% CI instead of 90% CI [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2015-07-08 19:29 (4002 d 04:01 ago) – Posting: # 15054
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Hi pjs,

❝ What could be the reason to use 96.7% CI (decreasing the patient risk ??? increasing the faith in product???)


❝ and what justification would have been given.


I have no actual idea, but I think some kind of multiplicity issue could have been the case here since they worked with a decreased alpha. Perhaps it was something with a semi-sequential design, multiple candidate formulations and/or interim picking of a final one for finalisation, or something along those lines?

Pass or fail!
ElMaestro

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