BE study results Evaluation [Study As­sess­ment]

posted by Vaibhav – India, 2022-06-14 22:57 (771 d 04:27 ago) – Posting: # 23057
Views: 1,942

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.

Complete thread:

UA Flag
Activity
 Admin contact
23,127 posts in 4,859 threads, 1,646 registered users;
79 visitors (0 registered, 79 guests [including 13 identified bots]).
Forum time: 03:25 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5