Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-19 01:48 CEST (UTC+2h)

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: 2,835

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

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,386 posts in 3,906 threads, 1,172 registered users;
online 15 (0 registered, 15 guests [including 10 identified bots]).

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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