Default rules [NCA / SHAM]

posted by mittyri – Russia, 2019-02-20 21:40 (582 d 07:14 ago) – Posting: # 19950
Views: 5,411

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

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