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RegisterScaling approach in steady state [Design Issues]
Dear All,
Can we adopt a ref scaling approach in a steady state design for highly variable drugs?
if yes, in such cases what are the parameters to consider for the scaling for USFDA & EMA submission studies.
Many thanks in advance.
Can we adopt a ref scaling approach in a steady state design for highly variable drugs?
if yes, in such cases what are the parameters to consider for the scaling for USFDA & EMA submission studies.
Many thanks in advance.
—
Regards,
AB
Regards,
AB
Complete thread:
- Scaling approach in steady stateAB 2013-01-10 08:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Scaling approach in steady state Helmut 2013-01-10 13:30
- Scaling approach in steady state AB 2013-01-11 13:42
- Only AUCt and Cmin Helmut 2013-01-11 14:11
- Scaling approach in steady state AB 2013-01-11 13:42
- Scaling approach in steady state Helmut 2013-01-10 13:30
Ing. Helmut Schütz