Russian Guidance – PK Data assay [NCA / SHAM]
Dear K@K
Regarding 6.1: I guess the Russian guidance refers to something like partialAUC.
What do you think about this parameter?:
partialAUC(0-Tmax)+(Tmax-T75%Cmax)
Regarding 6.2, IMHO it does not make sense for an individual PK parameter to have a reference to mean values. So I agree, this is very confusing. Partial AUC without initial absorption phase until mean steady state concentration is reached until decline after Tmax to individual 75%Cmax values? This does not make sense, right?
Kind regards
Dan
Regarding 6.1: I guess the Russian guidance refers to something like partialAUC.
What do you think about this parameter?:
partialAUC(0-Tmax)+(Tmax-T75%Cmax)
Regarding 6.2, IMHO it does not make sense for an individual PK parameter to have a reference to mean values. So I agree, this is very confusing. Partial AUC without initial absorption phase until mean steady state concentration is reached until decline after Tmax to individual 75%Cmax values? This does not make sense, right?
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Russian Guidance – PK Data assay Karthikeyan 2013-08-27 13:54
- Plateau-time etc. Helmut 2013-08-27 14:44
- Russian Guidance – PK Data assayDr_Dan 2013-08-27 15:39
- Russian Guidance – PK Data assay Helmut 2013-08-27 16:31
- t75% Dr_Dan 2013-08-27 16:56
- t75% Helmut 2013-08-27 17:37
- t75% mittyri 2013-08-28 09:51
- t75% (reporting only?) Helmut 2013-08-28 14:32
- t75% mittyri 2013-08-28 09:51
- t75% Helmut 2013-08-27 17:37
- t75% Dr_Dan 2013-08-27 16:56
- Partial AUC? Helmut 2013-08-28 17:42
- Partial AUC? Dr_Dan 2013-08-28 21:08
- Partial AUC? Karthikeyan 2013-08-29 14:04
- Partial AUC? Dr_Dan 2013-08-28 21:08
- Russian Guidance – PK Data assay Helmut 2013-08-27 16:31