FDA: Budesonide in vitro PBE [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2016-07-07 16:25 (3145 d 19:24 ago) – Posting: # 16479
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Hi mittyri,

❝ If I understood correctly, simulation is the best choice, something like this […]



THX; looks promising!

❝ Is that an enhancement request to "Swiss army knife for lazy guys dealing with BE studies"?:-D


I wouldn’t say so. IMHO there are other things on the to-do-list with a higher rate of importance. AFAIK this method is required by the FDA only for two products: Budesonide Suspension/Inhalation and Intravenous Iron Sucrose.

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