Steady State design [Design Issues]

posted by rajasekharkakarla – India, 2018-05-03 12:28  – Posting: # 18753
Views: 1,015

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]

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,268 posts in 4,098 threads, 1,314 registered users;
online 17 (1 registered, 16 guests [including 8 identified bots]).

That which is not controversial
is of no particular interest.    Johann Wolfgang von Goethe

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5