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RegisterResults Analysis [Study Assessment]
» 90% CI AUC: Lower limit - 98.35, Upper limit - 132.50, T/R ratio of AUC: 112.2
» 90% CI Cmax: Lower limit - 95.38, Upper limit - 127.80, T/R ratio of Cmax: 109.5
»
» Questions:
» 1. Primary reason for BE Failure?
Looking at your confidence intervals it looks like your ISCV computation may not be accurate, I am getting 33.6 for AUC. Your study is under powered!!!!!.
Assuming high bound of 34% ISCV and Ratio of 112 you 136 subjects (completers) for a standard 2x2 study design.
To improve probability of success go for 3-way (if your RLD CV is tight) or 4-way cross over replicated design with RSABE option. You have a shot at satisfying Bioequivalence.
Hope this helps
» 90% CI Cmax: Lower limit - 95.38, Upper limit - 127.80, T/R ratio of Cmax: 109.5
»
» Questions:
» 1. Primary reason for BE Failure?
Looking at your confidence intervals it looks like your ISCV computation may not be accurate, I am getting 33.6 for AUC. Your study is under powered!!!!!.
Assuming high bound of 34% ISCV and Ratio of 112 you 136 subjects (completers) for a standard 2x2 study design.
To improve probability of success go for 3-way (if your RLD CV is tight) or 4-way cross over replicated design with RSABE option. You have a shot at satisfying Bioequivalence.
Hope this helps
Complete thread:
- Results Analysis unique_one 2014-07-08 08:58 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Results Analysis ElMaestro 2014-07-08 10:08
- Results Analysis unique_one 2014-07-08 10:42
- Don’t hurry; explore consequences Helmut 2014-07-08 12:00
- Don’t hurry; explore consequences unique_one 2014-07-08 14:01
- The smaller a study, the more uncertain its results Helmut 2014-07-08 17:39
- The smaller a study, the more uncertain its results unique_one 2014-07-09 06:59
- The smaller a study, the more uncertain its results unique_one 2014-07-10 07:09
- The smaller a study, the more uncertain its results unique_one 2014-07-09 06:59
- The smaller a study, the more uncertain its results Helmut 2014-07-08 17:39
- Don’t hurry; explore consequences unique_one 2014-07-08 14:01
- 156 ? d_labes 2014-07-08 12:03
- 156 ? unique_one 2014-07-08 14:03
- Results Analysis Shuanghe 2014-07-08 12:57
- Results Analysis unique_one 2014-07-08 14:08
- Results Analysis Samaya B 2014-07-09 07:58
- bootstrap Shuanghe 2014-07-09 18:26
- bootstrap Weidson 2021-07-03 01:36
- Bootstrapping BE: An attempt in 🇷 Helmut 2021-07-08 13:50
- Bootstrapping BE: An attempt in 🇷 ElMaestro 2021-07-09 14:15
- Bootstrapping BE: Desultory thoughts Helmut 2021-07-09 14:50
- Bootstrapping BE: Desultory thoughts ElMaestro 2021-07-09 16:29
- Bootstrapping BE: Desultory thoughts Helmut 2021-07-09 21:04
- Bootstrapping BE: Desultory thoughts ElMaestro 2021-07-09 16:29
- Bootstrapping BE: Desultory thoughts Helmut 2021-07-09 14:50
- Bootstrapping BE: An attempt in 🇷 ElMaestro 2021-07-09 14:15
- Bootstrapping BE: An attempt in 🇷 Helmut 2021-07-08 13:50
- bootstrap Weidson 2021-07-03 01:36
- bootstrap Shuanghe 2014-07-09 18:26
- Results Analysis Samaya B 2014-07-09 07:58
- Results Analysis unique_one 2014-07-08 14:08
- Don’t hurry; explore consequences Helmut 2014-07-08 12:00
- Results Analysis unique_one 2014-07-08 10:42
- Results AnalysisAchievwin 2021-08-17 19:26
- Results Analysis ElMaestro 2014-07-08 10:08
Ing. Helmut Schütz