Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-10-17 02:07 CEST (UTC+2h)

forced BE? [Design Issues]

posted by Helmut Homepage - Vienna, Austria, 2017-08-07 14:26  - Posting: # 17671
Views: 899

Hi David,

» » [quote from ICE E9]
» » Did you ever see that in a protocol? I didn’t.
» Never saw it either, although at the planning stage a lot of sensitivity analysis are done (at least, in the studies I work with)

AFAIK, in phase III that’s regularly done. I know some people doing it in BE. However, it doesn’t make it to the protocol. Hence, the EC is left out in the rain.

» Not hard-core frequentist, but going bayesian is still a crime for some statisticians and I would only go that way if other alternatives are not available :-D


» » Again: Post hoc power. How relevant is it?
» It might be relevant, if you note a trend in approved studies: for instance, if most of them are significantly (still to be defined what might be significantly) overpowered and the assumptions defined in sample size calculation are far way from the observed parameters, I think this might be an issue that should handled and it is being neglected.

Agree. Concerning overpowering see this post and play around with the functions exppower.TOST() and expsampleN.TOST() in PowerTOST. Surprises guaranteed. See also this presentation (slide 8 and followings).

» By the regulators, which should be (again, imo) more open to share their information on CV and GMR of already approved drugs, and by the sponsors that should present strong justifications (as per ICH E9) on their protocols, such as sensitivity analysis and references that support their assumptions (other than "available literature" and "in-house data") and should look more carefuly to other design strategies available instead of just plugging a CV based on intuition.

Agree, again.

» Otherwise, we are assuming that sample size is magic performed by the sta­tis­tician to acchieve the maximum budget of the project :-D

Do you know Clarke’s third law?

Any sufficiently advanced technology is indistinguishable from magic.

[image]All the best,
Helmut Schütz 

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,394 Posts in 3,725 Threads, 1,071 registered users;
29 users online (0 registered, 29 guests).

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

BEBAC Ing. Helmut Schütz