General remarks [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2015-02-02 15:06 (4164 d 00:05 ago) – Posting: # 14353
Views: 26,368

Hi nobody,

❝ So: make your 25-28% something formulation…


Scaling depends on the CVw of the reference. If you are able to manufacture a new pro­duct with smaller variability you get a reward in sample size (same widening of the AR but tighter CI). Example (T/R 0.9, 80% power, 4-period full replicate):

CVwR CVwT  n
0.35 0.35 34
0.35 0.25 26


❝ …go with 31% in the study and you are on the lucky side of life, hu?


If you mean that the true CVwR is 25–28% and you observe 31%, yes. You scale the AR to 79.44–125.89% although the reference is not highly variable. Lucky punch for the pro­ducer, slightly increased risk for the patient.

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
23,655 posts in 4,993 threads, 1,571 registered users;
349 visitors (0 registered, 349 guests [including 18 identified bots]).
Forum time: 16:11 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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