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Registerone size fits all vs goal posts [NCA / SHAM]
Dear Mittyri!
Thank you for your remarkable example! I've got it. 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? If we have a large sample size in the study and noone presents the same pharmacokinetic features than it's a reason to think what that could be.
Don't believe in it cause I observe a lot of changes and improvements while using PHX through years
Another point is that I used PHX NCA like a standard candle (maybe regulators do it as well?). But it turns out that in some rare extreme cases it is worth to think about alternative approaches. Would it be accepted? How to be sure that the method stated in SAP would work better than PHX algo? Is it possible to explain in the report any disagreement with PHX output?
Thank you for your remarkable example! I've got it. 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? If we have a large sample size in the study and noone presents the same pharmacokinetic features than it's a reason to think what that could be.
❝ I don't think the default WNL NCA rules will change since it can break a lot of templates and projects. Name it as unhealthy and lazy conservatism 
Don't believe in it cause I observe a lot of changes and improvements while using PHX through years
Another point is that I used PHX NCA like a standard candle (maybe regulators do it as well?). But it turns out that in some rare extreme cases it is worth to think about alternative approaches. Would it be accepted? How to be sure that the method stated in SAP would work better than PHX algo? Is it possible to explain in the report any disagreement with PHX output?
—
"Being in minority, even a minority of one, did not make you mad"
"Being in minority, even a minority of one, did not make you mad"
Complete thread:
- AUC0-tau at steady state BNR 2016-03-31 22:46
![[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 postsAstea 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 postsAstea 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