Bioequivalence and Bioavailability Forum • BE study designs

BE study designs [Design Issues]

posted by Essar – 2006-01-17 05:53 (6818 d 00:24 ago) – Posting: # 55
Views: 25,785

❝ Your design is not balanced in respect to all effects in the model, in other words, 3 combinations of treatments are missing. The chance of regulatory acceptance of a 3×3 is close to zero.

❝ The simplest design you may apply is a Williams’ design (3-treatment, 3-period, 6-sequence):

Dear Helmut,
Thanks once again for taking the time out.

When you say that chance of regulatory acceptance of 3x3 is close to zero, you mean specifically for 3x3x3, or it is applicable to 3x3x6 design also?

Also, can you please let me know the reason for the same.

Now, I will start hunting for the references you have given me.

Regards,
Essar

Complete thread:

BE study designs Essar 2006-01-12 04:47
- BE study designs Helmut 2006-01-12 18:38
  - BE study designs Essar 2006-01-13 04:40
  - BE study designs Essar 2006-01-16 13:20
    - BE study designs Helmut 2006-01-16 15:39
      - BE study designsEssar 2006-01-17 04:53
        
        BE study designs Helmut 2006-01-17 09:27
      - BE study designs nguyenvo 2006-04-30 21:40
        
        sample size reference Helmut 2006-05-01 11:59
        BE study designs olacy 2006-06-23 09:28
        
        Reference (direct link) Helmut 2006-06-24 12:45
  - BE study designs shiv 2006-01-25 06:46
    - ANVISA?! Helmut 2006-01-25 13:37