Bioequivalence and Bioavailability Forum • Default rules

Default rules [NCA / SHAM]

posted by mittyri – Russia, 2019-02-20 22:40 (2232 d 11:00 ago) – Posting: # 19950
Views: 13,379

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:

AUC0-tau at steady state BNR 2016-03-31 22:46 [NCA / SHAM]
- AUC0-tau at steady state jag009 2016-03-31 23:05
  - AUC0-tau at steady state BNR 2016-03-31 23:43
    - RTFM Helmut 2016-04-01 00:59
      - RTFM BNR 2016-04-01 02:05
      - AUC0-τ estimation with time deviations Astea 2019-02-10 16:38
        
        AUC0-τ estimation with time deviations Helmut 2019-02-10 19:32
        
        Cτ for lin and lin-up/log-down Astea 2019-02-10 20:50
        
        Cτ by lin-/lin, lin-up/log-down, and λz Helmut 2019-02-11 01:45
        
        inter- vs extra- Astea 2019-02-11 19:46
        
        inter- vs extra- Helmut 2019-02-12 02:20
        No rule fits all mittyri 2019-02-14 12:55
        
        one size fits all vs goal posts Astea 2019-02-16 08:33
        
        one size fits all vs goal posts ElMaestro 2019-02-16 13:33
        
        Bias etc. Helmut 2019-02-16 14:26
        
        software: NCA not validated Helmut 2019-02-16 13:59
        
        no way out for NCA validation? mittyri 2019-02-20 21:22
        
        Default rulesmittyri 2019-02-20 21:40