It is, it is! [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2020-05-04 14:07  – Posting: # 21397
Views: 3,603

» 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


Cheers,
Helmut Schütz
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