Bioequivalence and Bioavailability Forum

Dear Alhas!

❝ can any one suggest the blood sampling points for bicalutamide as the Tmax is around 31.3h (from US RLD label)

OK, you are talking about the active isomer R(-)bicalutamide.

Some points to consider:
You must be able to show descriptively data of the inactive S(+) isomer as well. This complicates things, because the t_max of S(+) is about 4 hours only (and t_½ about 22 hours).
Therefore your sampling time points must be able to describe both profiles…
Due to the long half life of R(-) I would go with a parallel study; truncated AUC should do the job pretty well. In one study in 58 subjects we saw a t_max of R(-) in two subjects at 72 hours – to be on the safe side, I would sample until 96 hours.