Inflated type I error with fixed widened limits [RSABE / ABEL]

posted by d_labes  – Berlin, Germany, 2020-11-29 17:51 (237 d 01:33 ago) – Posting: # 22095
Views: 2,381

Dear Osama,

» ... how could this type I error inflation happen?

Imagine, you have a true CVwR of 30%. That means your true BE limits should be 80% ... 125%.
Now you performe a study but obtain an estimate of CVwR of 35%. Given this you use the widened (fixed) BE acceptance range of 75% ... 133.33%. With that acceptance range the BE decision is easier to obtain. This also happens if the true theta0 (GMR) is 125% (or 80%), i.e. bioinequivalence is what we have. Thus more than 5% of BE decision result, that means there is an alpha inflation.

Hope this makes sense to you.
May be Helmut has a better (paedogogical) explanation because he is an exceptionally gifted preacher :cool:.

Regards,

Detlew

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