which time points to use for calculation of kel [NCA / SHAM]

posted by ElMaestro  – Denmark, 2012-06-12 13:35 (4709 d 05:34 ago) – Posting: # 8703
Views: 12,027

Hi Samir,

❝ That seems reasonable but please explaine why last 4 and not 3 or 5 or 6


This is exactly why I say it is a subjective matter - it is a matter of judgement, opinion, gut feeling, instinct, etc. If you think the last 3, 4, 5 or 6 points all give you a linear piece then by all means go ahead and use the number of points that you find appropriate. You have freedom to do so because no guideline dictates how it should be done. At the end of the day you need to be reasonable to the extent that your judgement pleases the regulator.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,666 registered users;
57 visitors (0 registered, 57 guests [including 10 identified bots]).
Forum time: 19:09 CEST (Europe/Vienna)

Patients may recover in spite of drugs or because of them.    John Gaddum

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