asking the FDA… [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2016-07-07 15:44 (3631 d 15:59 ago) – Posting: # 16475
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Hi BE-proff

❝ I think the option is to request FDA how to do it.

❝ They are responsive guys so they will hardly refuse you ))


I would not bet on that. F.i. the FDA’s SAS-code for ABE in the partial replicate design (if no scaling is applied) fails to converge due to the over-specified model (regardless which software one uses). John sent a letter to Donald Schuirmann asking for a clarification and never received an answer. :-(

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