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 (251 d 21:51 ago) – Posting: # 20889
Views: 2,039

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
20,969 posts in 4,374 threads, 1,460 registered users;
online 21 (1 registered, 20 guests [including 11 identified bots]).
Forum time: Thursday 14:46 CEST (Europe/Vienna)

It is a good morning exercise for a research scientist
to discard a pet hypothesis every day before breakfast.
It keeps him young.    Konrad Lorenz

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