General remarks [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2015-02-02 15:06 (3753 d 21:36 ago) – Posting: # 14353
Views: 22,595

Hi nobody,

❝ So: make your 25-28% something formulation…


Scaling depends on the CVw of the reference. If you are able to manufacture a new pro­duct with smaller variability you get a reward in sample size (same widening of the AR but tighter CI). Example (T/R 0.9, 80% power, 4-period full replicate):

CVwR CVwT  n
0.35 0.35 34
0.35 0.25 26


❝ …go with 31% in the study and you are on the lucky side of life, hu?


If you mean that the true CVwR is 25–28% and you observe 31%, yes. You scale the AR to 79.44–125.89% although the reference is not highly variable. Lucky punch for the pro­ducer, slightly increased risk for the patient.

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