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RegisterSample size/power for PD BE study 3-way crossover [Power / Sample Size]
Dear Coja66
In order to understand your problem additional information is needed. First HVD: regarding PK or PD? Highly intra-subject variability regarding pharmacokinetic parameters do not necessary mean highly intra-subject variability regarding pharmacodynamic outcome although in general pharmacodynamic parameters are more variable than kinetic. What is the range of the PD parameter?
Second: Your study, is it a proof-of-concept study or a pivotal BE study? I personally would not recommend to test two test formulations in a pivotal study. In case of highly variable drugs I recommend to use a full replicate design. In general a 6x3 way design is not possible due to blood loss, but in your case it is different. Increasing the numbers of periods also means to increase the probability of drop outs.
Kind regards
Dan
In order to understand your problem additional information is needed. First HVD: regarding PK or PD? Highly intra-subject variability regarding pharmacokinetic parameters do not necessary mean highly intra-subject variability regarding pharmacodynamic outcome although in general pharmacodynamic parameters are more variable than kinetic. What is the range of the PD parameter?
Second: Your study, is it a proof-of-concept study or a pivotal BE study? I personally would not recommend to test two test formulations in a pivotal study. In case of highly variable drugs I recommend to use a full replicate design. In general a 6x3 way design is not possible due to blood loss, but in your case it is different. Increasing the numbers of periods also means to increase the probability of drop outs.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Sample size/power for PD BE study 3-way crossover Coja66 2011-03-28 14:22
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample size/power for PD BE study 3-way crossover Helmut 2011-03-29 14:34
- Sample size/power for PD BE study 3-way crossover Coja66 2011-03-29 15:31
- Sample size/power for PD BE study 3-way crossoverDr_Dan 2011-03-30 10:13
- Sample size/power for PD BE study 3-way crossover Coja66 2011-03-30 11:36
- Sample size/power for PD BE study 3-way crossover ElMaestro 2011-03-30 13:48
- Off topic (W.H.) Helmut 2011-03-30 13:59
- Off topic (W.H.) ElMaestro 2011-03-30 14:54
- Off topic (W.H.) Helmut 2011-03-30 15:05
- Off topic (W.H.) ElMaestro 2011-03-30 14:54
- Off topic (W.H.) Helmut 2011-03-30 13:59
- Sample size/power for PD BE study 3-way crossover ElMaestro 2011-03-31 19:55
- Sample size/power for PD BE study 3-way crossover jdetlor 2011-04-01 15:52
- Sample size/power for PD BE study 3-way crossover ElMaestro 2011-04-01 16:19
- Sample size/power for PD BE study 3-way crossover jdetlor 2011-04-01 16:56
- Sample size/power for PD BE study 3-way crossover ElMaestro 2011-04-01 17:14
- Sample size/power for PD BE study 3-way crossover jdetlor 2011-04-01 21:51
- Sample size/power for PD BE study 3-way crossover ElMaestro 2011-04-01 17:14
- Sample size/power for PD BE study 3-way crossover jdetlor 2011-04-01 16:56
- Sample size/power for PD BE study 3-way crossover ElMaestro 2011-04-01 16:19
- Sample size/power for PD BE study 3-way crossover jdetlor 2011-04-01 15:52
- Sample size/power for PD BE study 3-way crossover ElMaestro 2011-03-30 13:48
- Sample size/power for PD BE study 3-way crossover Coja66 2011-03-30 11:36
- Sample size/power for PD BE study 3-way crossoverDr_Dan 2011-03-30 10:13
- Sample size/power for PD BE study 3-way crossover Coja66 2011-03-29 15:31
- Sample size/power for PD BE study 3-way crossover Helmut 2011-03-29 14:34
Ing. Helmut Schütz