BLQ handling in BE study where all values in one profile are BLQ [NCA / SHAM]

posted by Ibrahim Komeil – Egypt, 2019-11-28 15:55 (690 d 17:35 ago) – Posting: # 20889
Views: 2,770

Hi Simon

I think that we will face a problem in optimization the linearity for this volunteer and weighing the calibration curve, i think that you can't modify the bioanalytical validation for single volunteer. But you can do it for all volunteers not for one person only by changing in LLOQ

Regards,


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Complete thread:

Activity
 Admin contact
21,738 posts in 4,546 threads, 1,543 registered users;
online 8 (0 registered, 8 guests [including 4 identified bots]).
Forum time: Tuesday 10:30 CEST (Europe/Vienna)

Sometimes the key to an answer is found
in the way you formulate the question.    David Brin

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