Different ka and f [Power / Sample Size]

posted by sam – India, 2012-11-28 13:38 (4961 d 01:43 ago) – Posting: # 9615
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Dear Helmut

It’s a nice Joke and I am very glad that I have added your joke in my memories.
Thanks for your nice and explanatory mail.
In case of the Fed study the ISCV is more than 30%. Based on that should I go for the partially or fully replicate design along with the reformulation.
Since this I am adding one more variable like partially replicate and fully replicate and second variable is reformulation. So I am bit doubtful will it be a wise decision to go with both the variables in a singly time to save the time lines.
Plz also suggest if this is really a highly variable drug product with some references, if possible.
Hope for the positive reply.

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