Bioequivalence and Bioavailability Forum

Dear members,

I am working on Risperidone 1 mg orally desintegrating tablet.

The lable claim indicate:-
1. T_max: Risperidone- 1 hr.
9-OH Risperidone- 3 hrs. in Extensive metabolizers & 17 hrs. in poor metabolizers.

2. Apperent T_1/2: Risperidone- 3 hrs. in Extensive metabolizers & 20 hrs. in poor metabolizers.
9-OH Risperidone- 21 hrs. in Extensive metabolizers & 30 hrs. in poor metabolizers.

3. Steady State conc.: Risperidone- 1 day in Extensive metabolizers & 5 days in poor metabolizers.
9-OH Risperidone- 5-6 days in Extensive metabolizers

So, I want to ask that, while designing protocol for 2-way cross-over study, what in the significance of Extensive & poor metabolizers?

For calculating total sampling Hrs. and wash-out period, is it nessary to consider poor metabilizers effect?

So kindly guide me regarding the same...

Thanks n Regards,
Rahul...