Study design [Regulatives / Guidelines]

posted by ABP – India, 2013-01-01 19:06 (4924 d 15:36 ago) – Posting: # 9775
Views: 4,251

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

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