Bioequivalence and Bioavailability Forum

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.