LLOQ ≤5% of individual Cmax-values [Bioanalytics]

posted by mittyri – Russia, 2018-10-18 21:50 (2072 d 21:15 ago) – Posting: # 19473
Views: 4,452

Hi Helmut and Beholder,

Let's take a hypothetical example
Due to high intersubject variability we got some periods for some (not many) subjects less than 5% of LLOQ.
1. Would you ask analytical lab to revalidate the method and reanalyze those profiles again or since analytical part is over, there's no way to change the method when playing part starts (Cmax estimation is PK part, right?)

2. Do you think the reasons to exclude that subjects are feasible enough?
Have you ever been asked to do that?

For me this is mind-blowing since the applicants should invest money not only in dropouts, but in extreme metabolizes too! The power loss for replicate designs is more significant (double the subject data)

PS: moreover, that criterion (Cmax< 20*LLOQ) is not listed in EMA GL as a reason for subject exclusion

Kind regards,

Complete thread:

UA Flag
 Admin contact
23,059 posts in 4,841 threads, 1,665 registered users;
42 visitors (0 registered, 42 guests [including 8 identified bots]).
Forum time: 19:06 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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