Significance [Power / Sample Size]

posted by The Outlaw Torn – Europe, 2012-11-20 08:56 (4468 d 01:41 ago) – Posting: # 9556
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Goodmorning everyone,

I have a question. Let's say Cmax for the test product is somewhat lower than for the reference product, but the confidence intervals are well within the acceptance criteria of 80 to 125% though it does not include unity (ie. 85 to 97). Let's say that during a deficiency letter an assessor claims the difference is significant. On what basis can they claim this significant difference (our client believes it is because the F-factor/test for treatment is significant—is this an appropriate test to use in this instance and can someone explain what it means in this context)? And how would one go about responding to such a claim (of significance)?

Personally, I'm focusing on the study results being compliant with the guideline requirements (Cmax is within the confidence intervals). Since this is the case, whatever difference in Cmax between test and reference products are non-significant. Is this correct? Comments?

Thank you in advance for any feedback you can provide.


Category changed. [Helmut]

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