Steady State design [Design Issues]

posted by rajasekharkakarla – India, 2018-05-03 12:28  – Posting: # 18753
Views: 1,104

Dear Sir/Madam,

I have some doubts in designing study state protocols.

Example: Tamsulosin

how to fix number of days to dosing

how to fix number of doses per day

My regular practice is if label/smpc states achievement of steady-state concentrations by the fifth day of once-a-day dosing for Tamsulosin, i will design the study state protocol with once a day dosing for five days. but i want to know the exact scientific rationale behind this.

please help me...

Regards,
Rajasekhar


Edit: Category changed; see also this post #1. [Helmut]

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