mindblowing [Two-Stage / GS Designs]
I think I overlooked this:
This was a two stage, four period, cross-over, block randomized, replicate design, single dose bioavailability study in healthy volunteers without charcoal blockade. Forty-eight healthy volunteers (24 males and 24 females, aged 18-55 years) were enrolled in the first stage according to study protocol.
Bioequivalence was reached at the first stage according to protocol; therefore the second stage of the study was not required to be performed. There were four periods in the first stage: both test and reference product were given twice according to a replicated design.
Alpha 2.94%. Approved in Germany, Sweden, Portugal, Iceland, Hungary, Italy, 2015


This was a two stage, four period, cross-over, block randomized, replicate design, single dose bioavailability study in healthy volunteers without charcoal blockade. Forty-eight healthy volunteers (24 males and 24 females, aged 18-55 years) were enrolled in the first stage according to study protocol.
Bioequivalence was reached at the first stage according to protocol; therefore the second stage of the study was not required to be performed. There were four periods in the first stage: both test and reference product were given twice according to a replicated design.
Alpha 2.94%. Approved in Germany, Sweden, Portugal, Iceland, Hungary, Italy, 2015



—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Replicated 4×2 and two-stage-design, in the same protocol Mauricio Sampaio 2015-04-06 08:37 [Two-Stage / GS Designs]
- Replicated 4×2 and two-stage-design, in the same protocol ElMaestro 2015-04-06 08:53
- Science fiction Helmut 2015-04-06 14:20
- Science fiction Dr_Dan 2016-03-04 10:33
- mindblowingElMaestro 2016-10-11 07:44
- Natural constant as usual; not for reference-scaling Helmut 2016-10-11 09:50
- Consistency DavidManteigas 2016-10-11 11:25
- Natural constant as usual; not for reference-scaling Helmut 2016-10-11 09:50