Russian Guidance – PK Data assay [NCA / SHAM]
Hi Dan & K@K,
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).
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.
❝ 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.
- 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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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 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
- 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 assayHelmut 2013-08-27 16:31