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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.
» 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
Kind regards,
Mittyri
Complete thread:
- AUC0-tau at steady state BNR 2016-03-31 22:46 [NCA / SHAM]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 rules mittyri 2019-02-20 21:40
- one size fits all vs goal posts ElMaestro 2019-02-16 13:33
- one size fits all vs goal posts Astea 2019-02-16 08:33
- inter- vs extra- Astea 2019-02-11 19:46
- Cτ by lin-/lin, lin-up/log-down, and λz Helmut 2019-02-11 01:45
- Cτ for lin and lin-up/log-down Astea 2019-02-10 20:50
- AUC0-τ estimation with time deviations Helmut 2019-02-10 19:32
- RTFM Helmut 2016-04-01 00:59
- AUC0-tau at steady state BNR 2016-03-31 23:43
- AUC0-tau at steady state jag009 2016-03-31 23:05
Ing. Helmut Schütz