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RegisterSteady state [Regulatives / Guidelines]
Hi All,
I am little bit confused with this statement.
In all other cases, where accumulation is likely (AUC(0-τ) after the first dose covers less than 90% of mean AUC(0-∞)) a multiple dose study is required. Generally, steady-state studies should be performed under the conditions concerning concomitant food intake recommended in the SmPC for the originator product.
If for any drug concomittant food intake is reccomended and it shows no accumulation (AUC(0-τ) after the first dose covers less than 90% of mean AUC(0-∞)) then in that case should we go for steady state or not?
I am little bit confused with this statement.
In all other cases, where accumulation is likely (AUC(0-τ) after the first dose covers less than 90% of mean AUC(0-∞)) a multiple dose study is required. Generally, steady-state studies should be performed under the conditions concerning concomitant food intake recommended in the SmPC for the originator product.
If for any drug concomittant food intake is reccomended and it shows no accumulation (AUC(0-τ) after the first dose covers less than 90% of mean AUC(0-∞)) then in that case should we go for steady state or not?
—
Kumar Naidu
Kumar Naidu
Complete thread:
- Type of study in modified release formulation EMEA Compliance 2014-03-13 09:43 [Regulatives / Guidelines]
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- Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 12:53
- Type of study in modified release formulation EMEA nobody 2014-11-27 11:37
- Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 11:02
Ing. Helmut Schütz