BE study results Evaluation [Study As­sess­ment]

posted by Vaibhav – India, 2022-06-14 22:57 (172 d 08:46 ago) – Posting: # 23057
Views: 645

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

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.

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