general remark [Design Issues]

posted by ElMaestro  – Denmark, 2015-11-24 17:50 (3370 d 16:43 ago) – Posting: # 15666
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Hi Kishpokuri,

sample size in BE (regardless of whether we talk BE under the US or EU definition / regardless of whether we discuss PK or PD) will always be depending on your desired level of power, as well as the true (estimated) relative performance of your product (measured as OIP difference) and the variability associated with this similarity measure. So let's hear your thoughts about them. Add to that, please, some thoughts about dropout rates and your statistical model.

Pass or fail!
ElMaestro

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