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

posted by ElMaestro  – Denmark, 2018-02-07 22:37  – Posting: # 18376
Views: 9,039

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.

if (3) 4

x=c("Foo", "Bar")
b=data.frame(x)
typeof(b[,1]) ##aha, integer?
b[,1]+1 ##then let me add 1


Best regards,
ElMaestro

“(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures.” New York Times (ed.), June 9, 2018.

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,488 posts in 4,135 threads, 1,336 registered users;
online 7 (0 registered, 7 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 00:52 CEST

No rational argument will have a rational effect on a man
who does not want to adopt a rational attitude.    Karl R. Popper

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5