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RegisterSelection of points for Elimination rate constant [NCA / SHAM]
Dear All,
Kindly clarify following point.
For AUC(0 to inf) for determination of Kel (elimination rate constant), shall we include Tmax point also for lambda _z lower.
Is there any specific guidance is there to fix lambda z lower or not to take Tmax point
If Tmax point is included for 20 % subjects, will there be any query from regulators.
Both Cmax and AUC(0 to t) are passed.
Subject experts in this forum can kindly give their opinion / advise.
Thanks for your support
Kindly clarify following point.
For AUC(0 to inf) for determination of Kel (elimination rate constant), shall we include Tmax point also for lambda _z lower.
Is there any specific guidance is there to fix lambda z lower or not to take Tmax point
If Tmax point is included for 20 % subjects, will there be any query from regulators.
Both Cmax and AUC(0 to t) are passed.
Subject experts in this forum can kindly give their opinion / advise.
Thanks for your support
Complete thread:
- Selection of points for Elimination rate constantryraman2661 2023-12-23 08:41 [NCA / SHAM]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Don’t include tmax Helmut 2023-12-23 11:46
- Don’t include tmax ryraman2661 2023-12-26 08:40
- Don’t include tmax Helmut 2023-12-23 11:46
Ing. Helmut Schütz