Power and type I adjustment for 222BE when several PK prams considered [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2018-02-07 23:37 (2357 d 03:37 ago) – Posting: # 18376
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Hi Louis,

❝ Can anyone direct me towards a thread where it is discussed/presented how to deal with alpha adjustment and power in case of multiplicity (AUC and Cmax considered at the same time)? Both CO and Parallel designs.


There is no alpha adjustment.
You need to show BE for both, usually. Sometimes even AUC in several flavours.

AUC and Cmax are positively correlated. That's something you may wish to factor in for sample size. However, in practice this requires a model for the correlation itself (for which nothing generally can be said) and besides it actually works quite well if you just dimension it according to the worst-case metric which tends to be Cmax.

Pass or fail!
ElMaestro

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