Suggested Administration [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2007-04-14 22:05 (7010 d 19:58 ago) – Posting: # 671
Views: 3,937

Dear Shankar / Imran!

❝ We are planning biostudy on dispersible tablet, in this we are going to

❝ compare Test formulation (dispersible tablet) with reference formulation

❝ (oral solution). Test formulation will be dispersed in 30 ml of water and

❝ Reference formulation will be a 25 ml solution.


May I assume you will adminster both formulations (dispersion/solution) from a small cup?

❝ My question is how much volume of water should be administered with Test

❝ or Reference Formulation at the time of dosing, ie, either 240 ml or

❝ less.


Try to follow the administration you have planned to be stated in the SPC / the product's labeling.
Whatever volume you are aiming at, this volume should be the total during administration in the study. If you administer the dispersion from a small cup, you should rinse the cup a least once with a defined amount of water (some particles show nasty adhesion).
If you want to go with 240 ml total, fine:
test: 30 ml dispersion + 30 ml rinse + 180 ml water
ref.: 25 ml solution + 25 ml rinse + 190 ml water

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
115 visitors (0 registered, 115 guests [including 17 identified bots]).
Forum time: 18:03 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5