Bioequivalence and Bioavailability Forum • Back Calculating Sample Size

Back Calculating Sample Size [Power / Sample Size]

posted by Sereng – USA, 2022-05-12 19:40 (1005 d 07:32 ago) – Posting: # 22977
Views: 4,523

Dear colleagues, if you have data from a completed BE study where the upper bound of the 90% CI of Cmax was outside the acceptance range, is it possible to calculate a new sample size that would likely meet the BE requirements (or declare futility)? In this case, the following are details of the completed BE study, where the reference drug Cmax had almost twice the CV of the Test drug.

Parallel Group Design
Two Groups (n=70/group)
Cmax (Ref): 478 +/- 434 (mean +/- SD)
Cmax (Test): 489 +/- 909 (mean +/- SD)
Ratio (90% CI): 109.00 (87.00-135.00)

Regards,

—
Biostatistically Challenged CEO

Complete thread:

Back Calculating Sample SizeSereng 2022-05-12 17:40 [Power / Sample Size]
- Back Calculating Sample Size ElMaestro 2022-05-12 22:29
  - Back Calculating Sample Size Helmut 2022-05-12 23:10
    - Back Calculating Sample Size ElMaestro 2022-05-13 01:38
    - Back Calculating Sample Size Sereng 2022-05-18 05:32
      - PowerTOST: Total sample size Helmut 2022-05-18 08:55
  - Back Calculating Sample Size dshah 2022-05-13 11:54
    - Algebra Helmut 2022-05-16 15:01
      - Algebra d_labes 2022-05-16 18:58
- Parallel designs: Don’t use the (conventional) t-test! Helmut 2022-05-17 14:17