Bioequivalence and Bioavailability Forum • Russian Guidance

Russian Guidance – PK Data assay [NCA / SHAM]

posted by Dr_Dan – Germany, 2013-08-27 17:39 (4313 d 10:03 ago) – Posting: # 11358
Views: 10,130

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

—
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
  - 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