Upper bound in RSABE ≤0 [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2019-02-02 15:15 (2295 d 05:31 ago) – Posting: # 19844
Views: 7,222

Hi Nirali,

❝ If the 95% upper bound for Cmax parameter is 0.002, should we conclude this study as a bioequivalent for Cmax?


No, since the upper bound has to be less or equal to zero. No rounding here …

❝ There is no specific criteria given for 95% upper bound in the OGD of Warfarin Sodium.


≤0 is the general rule for the FDA’s RSABE.
See also Jay’s post above, this thread, and a paper of the two Lász­lós.*



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
23,424 posts in 4,927 threads, 1,671 registered users;
137 visitors (0 registered, 137 guests [including 12 identified bots]).
Forum time: 21:46 CEST (Europe/Vienna)

A statistical analysis, properly conducted, is a delicate dissection of
uncertainties, a surgery of suppositions.    Micheal J. Moroney

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