WHO lamenting about terminology? [BE/BA News]

posted by d_labes  – Berlin, Germany, 2020-12-07 15:35 (571 d 07:51 ago) – Posting: # 22124
Views: 2,488

Dear Helmut,

» Coming back to the WHO’s rant:

The calculation of the 90% confidence interval (CI) of the mean test/comparator ratio for the primary PK parameters should not be confused with the two one-sided t-tests employed to reject the null hypothesis of non-equivalence. The end result is the same, but these are not the same calculations.


» IMHO, they are just fed up reading “TOST” whilst the CI inclusion approach acc. to the GL was actually performed.

Totally correct to lament about that fact, I think. It should unequivocally described in the protocol or the SAP which calculations will be done :yes:. The CI approach will be the favorite I think. It is requested in all guidelines about BE studies, if I dont err.

Regards,

Detlew

Complete thread:

UA Flag
Activity
 Admin contact
22,181 posts in 4,647 threads, 1,572 registered users;
online 9 (0 registered, 9 guests [including 3 identified bots]).
Forum time: Saturday 00:27 CEST (Europe/Vienna)

Reach for the stars,
even if you have to stand on a cactus.    Susan Longacre

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