Bioequivalence and Bioavailability Forum • Curiosity: Running BE studies with more than 2 arms

Curiosity: Running BE studies with more than 2 arms [Design Issues]

posted by jag009 – NJ, 2012-06-11 17:01 (4758 d 17:36 ago) – Posting: # 8683
Views: 11,195

Hi everyone,

I have a question. If there is a FDA a draft BE guidance for a product specifing the type of 2 way crossover studies that need to be conducted:

2-way crossover (Test vs Reference) fasting
2-way crossover (Test vs Reference) fed

What if we end up running a 4-way crossover involving 3 test formulations vs 1 Reference for each study? Everything will be the same except for 2 extra arms. The reason we are doing this is because we want to bypass the pilot study.

Would that be doable? The only issue I can see (beside the cost) is the ethical issue because we will (obviously) draw more blood samples per subject, and may have a larger sample size due to potential dropouts since the length of the study is doubled.

I believe FDA allows the use of an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Do you think the agency will have an issue with the approach?

Thanks

John

Complete thread:

Curiosity: Running BE studies with more than 2 armsjag009 2012-06-11 15:01 [Design Issues]
- Common variance! Helmut 2012-06-11 16:23
  - Common variance! jag009 2012-06-11 17:25
    - Common variance! Helmut 2012-06-11 17:35
      - Common variance! jag009 2012-06-11 20:03
        
        Common variance! ElMaestro 2012-06-11 20:34
        
        Common variance! Helmut 2012-06-12 01:03
        
        Common variance! ElMaestro 2012-06-12 13:22
  - Common variance! jag009 2012-06-12 19:56
    - What if I run a study with 2 references? jag009 2012-06-12 20:00
    - Common variance! Helmut 2012-06-12 20:39
      - Two References d_labes 2012-06-13 09:11
        
        Two References jag009 2012-09-10 22:48
        
        Two treatments only d_labes 2012-09-11 08:20
  - Common variance! jag009 2012-06-13 16:08