Bioequivalence and Bioavailability Forum • Pivotal study from pilot's data

Pivotal study from pilot's data [Power / Sample Size]

posted by yuvrajkatkar – Pune, Maharashtra (India), 2009-12-17 07:20 (6033 d 08:50 ago) – Posting: # 4489
Views: 8,202

Dear Sir,

Recently, I have analysed one Pilot study data.

In this study,

T/R ratios for Cmax, AUC0-t and AUC0-inf were 99.64%, 96.14% and 116.66%.

90% CI were not within the Bioequivalence Limit (80%-125%).

Now, I want to calculate sample size for Pivotal Study,

Is it right way to calculate sample size based on assumption (i.e maximum 10% T/R ratio difference?

Please suggest me

Edit: New thread created, category and subject line changed. [Helmut]

—
Best Regards,
Yuvraj

Thread locked

Complete thread:

Pivotal study from pilot's datayuvrajkatkar 2009-12-17 06:20
- AUCinf » AUCt?? Helmut 2009-12-17 18:17
  - AUCinf » AUCt?? yuvrajkatkar 2009-12-19 08:05
    - AUCinf » AUCt?? Helmut 2009-12-19 12:40
      - AUCinf » AUCt?? yuvrajkatkar 2009-12-19 13:38
        
        AUCinf » AUCt?? Helmut 2009-12-19 18:41
- Pivotal study from pilot's data ElMaestro 2009-12-18 23:32