Method not sensitive enough [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2019-12-18 16:16 (1562 d 18:55 ago) – Posting: # 20993
Views: 3,220

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 🖖🏼 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, 1,636 registered users;
116 visitors (0 registered, 116 guests [including 10 identified bots]).
Forum time: 11:12 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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