GRLS data [Power / Sample Size]

posted by Ohlbe – France, 2019-03-14 00:08  – Posting: # 20033
Views: 1,824

Dear Mittyri,

» By the way GRLS says that at least 2 companies performed BEQ studies. The sample size was (unfortunately we don't know exactly what 'the number of patients' means - sample size? number of subjects intended to be screened?) not more than 22 and 40. I would say this is not HVD.

Well, it depends... Does it say whether this sample size was sufficient to conclude ? Maybe they tried their luck (as considered by Elena) and failed with a 90 % CI of 34 - 192 % :crying:

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
20,793 posts in 4,353 threads, 1,445 registered users;
online 13 (0 registered, 13 guests [including 6 identified bots]).
Forum time: 03:30 CEST (Europe/Vienna)

In God we trust;
all others must bring data.    W. Edwards Deming

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