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RegisterBicalutamide having Long Half Life [Design Issues]
Dear All,
We need clarification on study design of BE of Bicalutamide 50mg tablets since, its long half life is around 150 hours and most of the available literatures have shown as parallel BE study with last time point as 672 hours and two-way cross over study with last time point as 672 hours.
Please suggest on study design of BE/BA study with Time-points to cover the AUC.
Regards,
Udaya Kumar K.
Biostatistician
We need clarification on study design of BE of Bicalutamide 50mg tablets since, its long half life is around 150 hours and most of the available literatures have shown as parallel BE study with last time point as 672 hours and two-way cross over study with last time point as 672 hours.
Please suggest on study design of BE/BA study with Time-points to cover the AUC.
Regards,
Udaya Kumar K.
Biostatistician
Complete thread:
- Bicalutamide having Long Half Lifeudayk 2019-10-04 12:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bicalutamide: Crossover not realistic Helmut 2019-10-07 14:59
- Bicalutamide: Crossover not realistic udayk 2019-10-10 09:10
- Bicalutamide: Crossover not realistic Helmut 2019-10-07 14:59
Ing. Helmut Schütz