Bioequivalence and Bioavailability Forum

Russian Guidance – PK Data assay [NCA / SHAM]

posted by Helmut  – Vienna, Austria, 2013-08-27 18:31 (4684 d 09:35 ago) – Posting: # 11359
Views: 12,438

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” t_75% 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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• Steinijans VW, Sauter R, Diletti E. Shape Analysis in Single- and Multiple-Dose Studies of Modified Release Products. In: Blume HH, Midha KK, editors. Bio-International 2. Stuttgart: medpharm Scientific Publishers; 1995. p. 193–206.

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Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Russian Guidance – PK Data assay Karthikeyan 2013-08-27 13:54 [NCA / SHAM] 
  • Plateau-time etc. Helmut 2013-08-27 14:44
  • Russian Guidance – PK Data assay Dr_Dan 2013-08-27 15:39
    • Russian Guidance – PK Data assayHelmut 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