Default rules [NCA / SHAM]

posted by mittyri – Russia, 2019-02-20 21:40  – Posting: # 19950
Views: 1,110

Dear Astea,

» But there could be some phylosophical thoughts: may be 60 is a miss (error or samples were mixed) than what whould be better - to calculate the square under 30-60-2 triangle carefully or to calculate the square under the curve assuming log elimination?
BE guidelines are strict enough (recalling the cases with substituted samples shown by Helmut?) - you cannot exclude the concentration point during PK analysis (even if you have a strong suspicion regarding that). Thus, if you exclude that point from λz estimation and then use λz for interpolation, you are ignoring that point. I would not recommend it (at least for BE).

» Don't believe in it cause I observe a lot of changes and improvements while using PHX through years :-)
The only DEFAULT thing was changed (please correct me) is a way for therapeutic areas calculation. All additional features like another PK parameters, Concentrations and λz rules do not affect default ways of computation. I mean if you run NCA from Time vs. Conc data in WNL 6.3 and then rerun in WNL 8.1, the values will be the same.

Kind regards,
Mittyri

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,478 posts in 4,133 threads, 1,333 registered users;
online 9 (0 registered, 9 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 20:59 CEST

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5