Log in
RegisterPatience... [Regulatives / Guidelines]
Dear all,
I have came across one reported study on Clinical trilas @ GOV about sequential design.
A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA.
Looking at the title and the given information, can it be called as an add on study design?
Thanks and best regards
Rahul
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
I have came across one reported study on Clinical trilas @ GOV about sequential design.
A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA.
Looking at the title and the given information, can it be called as an add on study design?
Thanks and best regards
Rahul
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Complete thread:
- Add on study design acceptability by the reg authorities rahul dixit 2010-10-26 07:08
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Add on study design acceptable with FDA/EMA Helmut 2010-10-26 14:00
- Add on study design acceptable with FDA/EMA rahul dixit 2010-10-26 14:55
- Add on study design acceptable with FDA/EMA rahul dixit 2010-10-27 09:49
- Add on design in US rahul dixit 2010-10-30 08:52
- Patience... Helmut 2010-10-30 15:12
- Patience...rahul dixit 2010-11-09 11:30
- About add-ons Helmut 2010-11-09 14:50
- Patience...rahul dixit 2010-11-09 11:30
- Patience... Helmut 2010-10-30 15:12
- Add on study design acceptable with FDA/EMA Helmut 2010-10-26 14:00
Ing. Helmut Schütz