“Forced BE” 101 [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2017-12-27 13:23 (2746 d 06:59 ago) – Posting: # 18097
Views: 36,799

❝ what about regulatory queries on "unintentional forced Bioequivalence"


What do you mean by unintentional?
Again: Stop estimating post hoc power! Either the study demonstrated BE or not.*
Going back to my example (study planned for 90% power): The chance to obtain a post hoc power of ≥95% is ~35%. Now what?
It only means thatHowever, the patient’s risk (α = probability of the Type I Error) is independent from the producer’s risk (β = probability of the Type II Error). The latter might be of concern for the IEC in study planning (see Yura’s example) whereas only the former is of regulatory concern – and not affected by power.

I still think that you calculations are wrong. Therefore, you are facing high values more often. Would you mind giving us the data ElMaestro and I asked for?



Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,677 registered users;
27 visitors (0 registered, 27 guests [including 4 identified bots]).
Forum time: 21:22 CEST (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important.    T. S. Eliot

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5