It is, it is! [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2020-05-04 16:07 (1885 d 08:36 ago) – Posting: # 21397
Views: 12,408

❝ I believe it must be this assessment report.:

❝ "the acceptance criteria for Cmax was widened to the acceptance range of 72.83-137.31%",


Almost my dear Dr Watson!
It’s the first study; results on page 7:
“… within-reference intra-subject CV of ln-transformed Cmax > 30% (42.6%), hence Cmax limits were widen[ed] to 73.31–136.42% using scaled-average-bioequivalence.”

library(PowerTOST)
identical(42.6 / 100, round(100 * CVwRfromU(136.42 / 100), 1))
[1] TRUE


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
23,425 posts in 4,928 threads, 1,684 registered users;
35 visitors (0 registered, 35 guests [including 11 identified bots]).
Forum time: 00:43 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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