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Registerlong half-life and large variability [Regulatives / Guidelines]
dear ElMaestro,
Thank you for your swift reply and sharing your thoughts.
There are two types of covariates (type 1: continous = subject specfic values; and type 2: categorical variable with a few levels).
At the first glance a different regulatory pathway might be worth considering based on a PK or exposure similarity evalulation as in such a case there could be more flexibility regarding acceptance of statistical models used to test for equivalence in PK metrics.
Happy to get your thoughts on this idea.
best regards
Martin
Thank you for your swift reply and sharing your thoughts.
There are two types of covariates (type 1: continous = subject specfic values; and type 2: categorical variable with a few levels).
At the first glance a different regulatory pathway might be worth considering based on a PK or exposure similarity evalulation as in such a case there could be more flexibility regarding acceptance of statistical models used to test for equivalence in PK metrics.
Happy to get your thoughts on this idea.
best regards
Martin
Complete thread:
- long half-life and large variability martin 2020-07-29 16:57 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- long half-life and large variability ElMaestro 2020-07-29 21:24
- long half-life and large variabilitymartin 2020-07-29 22:49
- long half-life and large variability ElMaestro 2020-07-30 08:17
- long half-life and large variability dshah 2020-08-10 06:18
- long half-life and large variability ElMaestro 2020-07-30 08:17
- long half-life and large variabilitymartin 2020-07-29 22:49
- long half-life and large variability Achievwin 2020-08-12 15:22
- long half-life and large variability Helmut 2020-08-12 15:53
- long half-life and large variability ElMaestro 2020-07-29 21:24
Ing. Helmut Schütz