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Registerpilot study [Design Issues]
Dear Sir,
I have to perform a 3 way cross over pilot study.
The test product is available in 4 strengths (e.q. 250, 500, 750 and 1000 mg) with dose proportionality between these strengths. The pharmacokinetics is not influenced by food.
Is a good design for this study a 3 way crossover study in fasted conditions with 3 sequences, 3 treatments and 3 periods with:
Test A – test product 4 x 250 mg
Test B – test product 1000 mg
Reference – reference (1000 mg)?
Thank you
and Marry Christmas!
I have to perform a 3 way cross over pilot study.
The test product is available in 4 strengths (e.q. 250, 500, 750 and 1000 mg) with dose proportionality between these strengths. The pharmacokinetics is not influenced by food.
Is a good design for this study a 3 way crossover study in fasted conditions with 3 sequences, 3 treatments and 3 periods with:
Test A – test product 4 x 250 mg
Test B – test product 1000 mg
Reference – reference (1000 mg)?
Thank you
and Marry Christmas!
Complete thread:
- pilot studyioanam 2006-12-22 09:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 3 way pilot study Helmut 2006-12-22 12:43
- 3 way pilot study ioanam 2007-01-09 09:55
- 3 way pilot study Helmut 2007-01-09 16:57
- 3 way pilot study ioanam 2007-01-09 09:55
- 3 way pilot study Helmut 2006-12-22 12:43
Ing. Helmut Schütz