Bioequivalence and Bioavailability Forum • Power in the pivotal study (EU)

Power in the pivotal study (EU) [Power / Sample Size]

posted by valivetiananth – India, 2018-05-31 15:49 (2147 d 00:03 ago) – Posting: # 18832
Views: 8,268

Dear All,

Greetings!!!

We have conducted a pivotal study for Europe with 48 subjects considering ~80% power, ISCV: 23%. The study was bioequivalent and 90% CI is within 80-125 for both Cmax & AUCt.

Power of Cmax and AUCt are 92% & 66% respectively. Kindly guide us how to justify the power less than 80% to HA.

Thanks
Valiveti

Complete thread:

Power in the pivotal study (EU)valivetiananth 2018-05-31 13:49 [Power / Sample Size]
- Stop estimating post hoc power! Helmut 2018-05-31 14:45
  - Stop estimating post hoc power! ElMaestro 2018-05-31 15:43
    - Confession Helmut 2018-05-31 17:16
      - Confession ElMaestro 2018-05-31 21:47
        
        Confession Helmut 2018-06-01 00:01
        
        Confession ElMaestro 2018-06-01 08:31
        
        Silly-O-Meter: Syntax Helmut 2018-06-01 13:42
        
        Silly-O-Meter: Syntax ElMaestro 2018-06-01 15:17
  - Stop estimating post hoc power! valivetiananth 2018-06-02 08:52
    - Eligible subjects? Helmut 2018-06-02 13:02
    - Don’t we deserve an answer? Helmut 2018-06-09 15:13