Suggested Administration [Design Issues]
Dear Shankar / Imran!
May I assume you will adminster both formulations (dispersion/solution) from a small cup?
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
❝ 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]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Issues in Dispersible tablet Imran 2007-04-12 12:33
- Suggested AdministrationHelmut 2007-04-14 20:05
