BE study results Evaluation [Study Assessment]
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.
CI: 100.51- 103.92
My question is can we proceed with sample size i.e. 54 or should re-calculate sample size based on EMA study results?
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.