Method not sensitive enough [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2019-12-18 14:16  – Posting: # 20993
Views: 1,329

Hi Aymanmy,

the requirement of LLOQ ≤ 5% of Cmax is used to assess carry-over. For the future: Never develop an analytical method based on an average Cmax. Since to have to comply for all subjects in all periods plan for the worst case (i.e., subjects with the lowest concentrations). This is particularly important for drugs with high between-subject variability.

» […] no detected concentrations in the predose samples for these subjects.

Yep but the method was not sensitive enough for these subjects. Hence, I support Dan’s suggestion (exclude the subjects and check whether you still pass BE).

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
20,794 posts in 4,354 threads, 1,446 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time: 01:25 UTC (Europe/Vienna)

I’m not a pessimist,
I’m just a well informed optimist.    José Saramago

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