Bicalutamide having Long Half Life [Design Issues]

posted by udayk – India, 2019-10-04 12:06  – Posting: # 20664
Views: 1,134

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

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