State it in the SAP & observe it [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2021-03-29 20:08 (1118 d 20:37 ago) – Posting: # 22298
Views: 1,917

Hi Loky do,

❝ If subject during bioequivalence study suffered from diarrhea before 2 median Tmax of immediate-release drug product, in this case, the optimum action to be done to exclude the subject from the study after the event directly?


If you know the median tmax:-D Sometimes in the label / SmPC for unfathomable reasons the mean is given.
State in the statistical analysis plan, and follow it (analyse the samples anyway).

❝ or subject continues the study and excludes his results from the calculations if his plasma concentration-time profile is unreliable?


I would not recommend that. Who / how decides what is ‘unreliable’? May lead to endless & fruitless discussions.

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
22,988 posts in 4,825 threads, 1,649 registered users;
36 visitors (0 registered, 36 guests [including 5 identified bots]).
Forum time: 16:45 CEST (Europe/Vienna)

As soon as we abandon our own reason, and are content
to rely upon authority, there is no end to our troubles.    Bertrand Russell

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