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Registert75% [NCA / SHAM]
Hi Helmut, Dan & K@K!
I have similar questions reading this guide.
There's no translation issue in chapter 6.2. In Russian we have the same.
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.
Would you explain this issue?
Kind regards,
mittyri
I have similar questions reading this guide.
There's no translation issue in chapter 6.2. In Russian we have the same.
❝ ❝ Would it be possible to be bioequivalent with regard to AUC and Cmax but failing with regard to t75%?
❝
❝ Yes, it is, The Lászlós (who else?) have shown that. Will excavate the reference.
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.
Would you explain this issue?
Kind regards,
mittyri
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Russian Guidance – PK Data assay Karthikeyan 2013-08-27 13:54
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- 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 assay Helmut 2013-08-27 16:31
Ing. Helmut Schütz