pooled CV from MR vs. IR [Power / Sample Size]

posted by ElMaestro  – Denmark, 2018-01-18 18:03 (1894 d 07:05 ago) – Posting: # 18217
Views: 3,662

Hi Hötzi,

❝ I suggest to perform a pilot study, a Two-Stage Design, or – if you want to go directly to the pivotal study – allow for a safety margin.

The generic way: Contact 37 different CRO's for a quotation for Biperiden IR filmcoated tablets, tell them you expect a T/R ratio of 106% or whatever on basis of dissolution studies and you hope for 80% power.
Some of them will respond back with a quotation involving a specific sample size, so you ask naïvely where that comes from. Then they will say that in the previous study they conducted on Biperiden IR the CV was so-and-so with this or that design "but please keep this information confidential". And voila, you have totally wasted a lot of time for employees in a boatload of companies but you got the type of information you were looking for.

Pass or fail!

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