Study design [Regulatives / Guidelines]
Dear Sir,
At the outset I wish each one of you a very Happy, Healthy and Prosperous New Year ahead.
I have one question about the study design. I would highly appreciate if you could help me understand the design issue for a FDA submission study. Can we have a different study design for fast and fed study in the same set of studies. For e.g. planning one of the studies as 3 WC and another one as 2 WC?
If yes, then could you please explain the rational.
Thanks in advance.
Yours,
ABP
At the outset I wish each one of you a very Happy, Healthy and Prosperous New Year ahead.

I have one question about the study design. I would highly appreciate if you could help me understand the design issue for a FDA submission study. Can we have a different study design for fast and fed study in the same set of studies. For e.g. planning one of the studies as 3 WC and another one as 2 WC?
If yes, then could you please explain the rational.
Thanks in advance.
Yours,
ABP
Complete thread:
- Study designABP 2013-01-01 18:06
- More details, please Helmut 2013-01-01 18:31
- More details, please ABP 2013-01-03 11:44
- ABE / RSABE Helmut 2013-01-03 12:27
- ABE / RSABE ABP 2013-01-09 08:01
- ABE / RSABE Helmut 2013-01-03 12:27
- More details, please ABP 2013-01-03 11:44
- More details, please Helmut 2013-01-01 18:31
