Russian Guidance – PK Data assay [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2013-08-27 18:31 (3866 d 12:40 ago) – Posting: # 11359
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Hi Dan & 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)


Interesting formula. No sure whether it “works” – intuitively I don’t think so. Last year in Moscow at two occassions my Russian colleagues were clear about the definiton. BTW, the “Plateau Time” t75% is a rather old PK metric.* László Endrényi in his presentations prefers “Peak Occupancy Time” (POT-75).

❝ Regarding 6.2, IMHO it does not make sense for an individual PK parameter to have a reference to mean values.


Oops, I didn’t see that. Very strange. This may be a translation issue as well. I have three English translations of the Russian GL differing in many points. :-|



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