Non-informative “profiles” [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2014-03-11 15:04 (3670 d 01:23 ago) – Posting: # 12597
Views: 9,307

Hi Ohlbe,

❝ […] If that's for the test formulation, I somewhat disagree... If you have a formulation that gives you no, or just one or two, concentration above the LLOQ, that's relevant information. I have no idea how these should be analysed, but just dropping them from the analysis is not an idea I'm comfortable with.


Fabrice stated that this was not a BE study. I think we need more information. The BE-GL talks about exclusion (in exceptional cases) if plasma concentrations are low after the reference product. But in the Q&A document’s section about gastric-resistant formulations we read:

Therefore, but only under the conditions that sampling times are designed to identify very delayed absorption and that the incidence of this outlier behaviour is observed with a comparable frequency in both, test and reference products, these incomplete profiles can be excluded from statistical analysis provided that it has been considered in the study protocol.

– which leads to the open question what a “comparable frequency” is. Last year in Bonn I pre­sented an example of four low profiles after one treatment and zero after the other in study in 24 subjects. Statistically the frequencies are not significantly different (5/0 would be with p 0496). Members of the PKWP unambiguously expressed their opinion that they don’t like that. ;-)

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
22,957 posts in 4,819 threads, 1,638 registered users;
80 visitors (0 registered, 80 guests [including 11 identified bots]).
Forum time: 16:27 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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