Russian Guidance – PK Data assay [NCA / SHAM]

posted by Dr_Dan  – Germany, 2013-08-27 17:39 (3865 d 19:43 ago) – Posting: # 11358
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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

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