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RegisterFirst Point Cmax (also ICH M13A) [Study Assessment]
Hi NK!
I would agree with Helmut but is the median Tmax- 15 min? If so, does the literature also supports the same? If yes, it means the sampling time points were not considered effectively. If no- then is median Tmax of 15 min observed for both treatments (considering 2TCO)? If it is only observed for Test or Reference- identify PKPD issue/toxicity challenges.
Divyen
Edit: Post moved. [Helmut]
I would agree with Helmut but is the median Tmax- 15 min? If so, does the literature also supports the same? If yes, it means the sampling time points were not considered effectively. If no- then is median Tmax of 15 min observed for both treatments (considering 2TCO)? If it is only observed for Test or Reference- identify PKPD issue/toxicity challenges.
Divyen
Edit: Post moved. [Helmut]
Complete thread:
- First Point Cmax USFDA NK 2024-09-13 06:48 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- First Point Cmax (also ICH M13A) Helmut 2024-09-17 08:38
- First Point Cmax (also ICH M13A) kimhuang 2024-11-27 08:49
- FDA M13A Helmut 2024-11-27 13:50
- First Point Cmax (also ICH M13A) kimhuang 2024-11-27 08:49
- First Point Cmax (also ICH M13A)dshah 2024-11-27 12:50
- First Point Cmax (also ICH M13A) Helmut 2024-09-17 08:38
Ing. Helmut Schütz