Log in
RegisterGo/No-go Decision for Pivotal Study [Power / Sample Size]
Dear All,
Greetings!
How to simulate the pilot BE study data?
For example, if the pilot study data available for 14 subjects (Eg. T/R ratio is 84% & 90% CI is 79 to 89), I would like to know if we perform the pivotal study with the same test formulation in higher sample size (based on the intra CV), what would be the results? (Eg. in 36 subjects or 48 subjects).
This will help us to take decision whether go/no go for the pivotal BE study.
Thanks
NK
Edit: Category changed; see also this post #1. [Helmut]
Greetings!
How to simulate the pilot BE study data?
For example, if the pilot study data available for 14 subjects (Eg. T/R ratio is 84% & 90% CI is 79 to 89), I would like to know if we perform the pivotal study with the same test formulation in higher sample size (based on the intra CV), what would be the results? (Eg. in 36 subjects or 48 subjects).
This will help us to take decision whether go/no go for the pivotal BE study.
Thanks
NK
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Go/No-go Decision for Pivotal StudyNK 2023-12-27 12:15 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Problematic T/R-ratio… Helmut 2023-12-27 13:27
- TSD? Helmut 2024-01-01 13:50
- sample size for TSD is better than for 1SD? mittyri 2024-01-01 19:54
- TSD? Helmut 2024-01-01 13:50
- Problematic T/R-ratio… Helmut 2023-12-27 13:27
Ing. Helmut Schütz