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RegisterSteady state [PK / PD]
Dear MGR
For SS study u need to estimate Cmin, Cmax, AUC0-tau, PTF.
These parameters can be calulated by any PK software such as WinNonlin or SAS. SS achived can be proved statistically by regression analysis. For more information u can refer USFDA guidance or CPMP guidlines for Extended release product.
I hope ur querry is answere to some extent
regards
Dr.Imran Khan
For SS study u need to estimate Cmin, Cmax, AUC0-tau, PTF.
These parameters can be calulated by any PK software such as WinNonlin or SAS. SS achived can be proved statistically by regression analysis. For more information u can refer USFDA guidance or CPMP guidlines for Extended release product.
I hope ur querry is answere to some extent
regards
Dr.Imran Khan
—
Dr.Imran Khan
Dr.Imran Khan
Complete thread:
- Statistical analysis of a steady state study MGR 2007-01-03 05:39 [PK / PD]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Statistical analysis of a steady state study H_Rotter 2007-01-04 16:05
- Steady stateImran 2007-01-10 09:52
Ing. Helmut Schütz