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RegisterBE study results Evaluation [Study Assessment]
Dear All,
This is my first post on this forum. Please ignore any mistake.
In 2016, we did BE study of Lenalidomide 25 mg capsule for EMA submission.
Enrolled N =54
Completed N =52
Now are planning to conduct another BE study with same Test formulation (used in EMA) for ANVISA.
Below are the EMA study results.
1. Cmax
T/R 104.13
CI: 97.89-110.77
CV: 18.97
Power: 99.99
2. AUCo-t
T/R 102.20
CI: 100.51- 103.92
CV: 5.08
Power:100
My question is can we proceed with sample size i.e. 54 or should re-calculate sample size based on EMA study results?
T/R- 105%
Power- 90%
CV- Approx. 19%
What could be the right approach for sample size calculation for ANVISA submission study?
Please let us know if you need more information.
This is my first post on this forum. Please ignore any mistake.
In 2016, we did BE study of Lenalidomide 25 mg capsule for EMA submission.
Enrolled N =54
Completed N =52
Now are planning to conduct another BE study with same Test formulation (used in EMA) for ANVISA.
Below are the EMA study results.
1. Cmax
T/R 104.13
CI: 97.89-110.77
CV: 18.97
Power: 99.99
2. AUCo-t
T/R 102.20
CI: 100.51- 103.92
CV: 5.08
Power:100
My question is can we proceed with sample size i.e. 54 or should re-calculate sample size based on EMA study results?
T/R- 105%
Power- 90%
CV- Approx. 19%
What could be the right approach for sample size calculation for ANVISA submission study?
Please let us know if you need more information.
Complete thread:
- BE study results EvaluationVaibhav 2022-06-14 20:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample size based on ‘overpowered’ study Helmut 2022-06-14 22:14
- Sample size based on ‘overpowered’ study Vaibhav 2022-06-15 21:00
- Sample size based on ‘overpowered’ study dshah 2022-06-16 10:43
- Sample size based on ‘overpowered’ study Vaibhav 2022-06-15 21:00
- Sample size based on ‘overpowered’ study Helmut 2022-06-14 22:14
Ing. Helmut Schütz