Log in
RegisterCovariates in PK [PK / PD]
Dear all,
I was wondering if I could get an opinion from the forum regarding covariate selection in PK studies. I realize covariate analysis in classic BE crossover studies is unusual but here I am assessing relative bioavailability (based on the usual AUC and Cmax metrics) of two formulations in a parallel design, phase III study. This is a patient population so I am trying to decide what covariates should be looked at in the PK analysis. I am thinking age, gender, race, weight (vs. bmi?), renal function, smoking. I think these are 'popular' covariates to look at but I wonder for the purpose of submissions if there is anything else regulators would be looking for? Does anyone have any suggestions or more experience with this?
Thank you for any input.
-sciguy
Edit: Category changed. [Helmut]
I was wondering if I could get an opinion from the forum regarding covariate selection in PK studies. I realize covariate analysis in classic BE crossover studies is unusual but here I am assessing relative bioavailability (based on the usual AUC and Cmax metrics) of two formulations in a parallel design, phase III study. This is a patient population so I am trying to decide what covariates should be looked at in the PK analysis. I am thinking age, gender, race, weight (vs. bmi?), renal function, smoking. I think these are 'popular' covariates to look at but I wonder for the purpose of submissions if there is anything else regulators would be looking for? Does anyone have any suggestions or more experience with this?
Thank you for any input.
-sciguy
Edit: Category changed. [Helmut]
Complete thread:
- Covariates in PKsciguy 2013-08-02 15:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Covariates in PK Helmut 2013-08-02 16:24
- Covariates in PK ElMaestro 2013-08-02 16:51
- Covariates in PK sciguy 2013-08-02 19:04
- Covariates in PK ElMaestro 2013-08-02 20:51
- Covariates in PK sciguy 2013-08-02 19:04
Ing. Helmut Schütz