Mean Ct profiles and LLOQ [NCA / SHAM]

posted by Frieda – 2008-10-29 18:40 (6018 d 09:18 ago) – Posting: # 2606
Views: 11,299

Dear all,

I'm a bit late in responding, just back from holiday.

Nonetheless, to expose my method:
I use the common arithmetic mean (±SD) and set values <LLOQ to zero in the absorption phase, use LLOQ/2 for values <LLOQ if the adjacent values are >LLOQ. I set the first terminal value <LLOQ to half the LLOQ and the subsequent ones to zero, and do not produce a mean if >50% of the actual values were <LLOQ.
My rationale is that it setting terminal values to zero straight away seems abrupt… (gut feeling, no real rationale). The ones in the middle will on average be somewhere between the LLOQ and zero and so I use half the LLOQ, also for AUC calculations.

Regards
Frieda

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
32 visitors (0 registered, 32 guests [including 7 identified bots]).
Forum time: 04:58 CEST (Europe/Vienna)

The true Enlightenment thinker, the true rationalist,
never wants to talk anyone into anything.
No, he does not even want to convince;
all the time he is aware that he may be wrong.    Karl R. Popper

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