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RegisterFixed Dose Combination Products [Design Issues]
posted by Helmut 
– Vienna, Austria, 2007-03-23 12:27 (7023 d 12:05 ago) – Posting: # 598
Views: 3,862
Dear Joy,
IMHO there should be no problem with such an approach.
BTW, although I've never seen such a study, I think it's a great idea.
You are really creative!
If you want to perform your study for an application with the FDA, please note:
IMHO there should be no problem with such an approach.
BTW, although I've never seen such a study, I think it's a great idea.
You are really creative!
If you want to perform your study for an application with the FDA, please note:
- There is not guideline on HVDs/HVDPs,
- FDA may want to see a minimum sample size (24 or 36?), and
- I would suggest waiting for results of the next meeting of the ACPSCP on 02 May 2007.
—
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. 🚮
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Fixed Dose Combination Products joyjac 2007-03-23 08:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fixed Dose Combination ProductsHelmut 2007-03-23 11:27
Ing. Helmut Schütz