Log in
RegisterPrimary and secondary parameters for SS study for EU [Regulatives / Guidelines]
Dear All,
This is to confirm what all primary and secondary PK parameters and criteria for BE should be considered for steady state study for a modified released tablet for EU submission?
As per current EU guideline it only mentions about AUC0-tau to be considered as the additional parameter for bioequivalence. Whereas for Steady State study for immediate release formulations it mentions parameters like AUC0-tau, Cmax,ss and Tmax,ss also.
But as per FDA we do consider Cmin, Cav, degree of fluctuation [(Cmax-Cmin)/Cav], and swing [(Cmax-Cmin)/Cmin].
Thanking you for your guidance in advance.
Ratnakar
This is to confirm what all primary and secondary PK parameters and criteria for BE should be considered for steady state study for a modified released tablet for EU submission?
As per current EU guideline it only mentions about AUC0-tau to be considered as the additional parameter for bioequivalence. Whereas for Steady State study for immediate release formulations it mentions parameters like AUC0-tau, Cmax,ss and Tmax,ss also.
But as per FDA we do consider Cmin, Cav, degree of fluctuation [(Cmax-Cmin)/Cav], and swing [(Cmax-Cmin)/Cmin].
Thanking you for your guidance in advance.
Ratnakar
Complete thread:
- Primary and secondary parameters for SS study for EUratnakar1811 2012-03-19 12:49 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- MR MD studies (EMA) Helmut 2012-03-19 14:18
- Non-superiority Jaime_R 2012-03-19 16:26
- Non-superiority Helmut 2012-03-19 16:59
- 'Non-superiority' - sample size d_labes 2012-03-20 15:48
- To err is Julious d_labes 2012-03-22 10:20
- PowerTOST 0.9-6 on CRAN Helmut 2012-03-30 14:13
- Non-superiority Helmut 2012-03-19 16:59
- Non-superiority Jaime_R 2012-03-19 16:26
- MR MD studies (EMA) Helmut 2012-03-19 14:18
Ing. Helmut Schütz