pooled CV from MR vs. IR [Power / Sample Size]
Hi Hötzi,
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.
❝ 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!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- CVwithin calculation of biperiden CECIF 2018-01-17 20:44 [Power / Sample Size]
- pooled CV from MR vs. IR Helmut 2018-01-18 16:46
- pooled CV from MR vs. IRElMaestro 2018-01-18 17:03
- pooled CV from MR vs. IR jag009 2018-01-21 03:32
- pooled CV from MR vs. IR Yura 2018-01-19 10:05
- TSD: BE in stage 1 Helmut 2018-01-19 12:21
- TSD: BE in stage 1 Yura 2018-01-19 13:21
- TSD: BE in stage 1 Helmut 2018-01-19 12:21
- pooled CV from MR vs. IRElMaestro 2018-01-18 17:03
- pooled CV from MR vs. IR Helmut 2018-01-18 16:46