t75% (reporting only?) [NCA / SHAM]
Hi mittyri!
Interesting, didn’t notice that before! Chapter 6.1 and 6.2 calls for the T/R ratios of these PK metrics and Chapter 7 calls for BE assessment of AUCt or AUC∞ (AUCτ,ss if applicable), Cmax, Cmax/AUCt, Cmax/AUC∞ (or Cmax/AUCτ,ss).
Your are closer to Russian regulators than I am. Duno, ask them. I would say simply report t75% etc.
❝ According russian guide t75% is calculated (chapter 6.1).
❝ So the question is: what can we do with this data?
❝ As you can see in chapter 7 (Statistical evaluation of bioequivalence) this parameter isn't used.
Interesting, didn’t notice that before! Chapter 6.1 and 6.2 calls for the T/R ratios of these PK metrics and Chapter 7 calls for BE assessment of AUCt or AUC∞ (AUCτ,ss if applicable), Cmax, Cmax/AUCt, Cmax/AUC∞ (or Cmax/AUCτ,ss).
❝ Would you explain this issue?
Your are closer to Russian regulators than I am. Duno, ask them. I would say simply report t75% etc.
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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. 🚮
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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 assay Helmut 2013-08-27 16:31
- 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