Bioequivalence and Bioavailability Forum • Definition of Full Replicate

Definition of Full Replicate [Design Issues]

posted by Brus – Spain, 2023-03-14 11:10 (17 d 18:19 ago) – Posting: # 23498
Views: 531

Dear Sereng,

From my understanding, this is not a replicate study. 4-ways is not always a replicate. There can be 4 periods but with 4 different formulations, or in different administration conditions, and in those cases it would not be a "full replicate". In your case, according to my humble opinion it is not a "full replicate" since they are administered in different conditions (fast VS fed). In your case, I think it would be more accurate to call it "4-ways food effects". At least in our own previous experiences, this is the way we have approached it.

Best regards,

Complete thread:

Definition of Full Replicate Sereng 2023-03-13 17:08 [Design Issues]
- Definition of Full Replicate Mahmoud 2023-03-13 20:27
  - Definition of Full Replicate Sereng 2023-03-13 23:38
    - Definition of Full Replicate Mahmoud 2023-03-14 08:44
      - Definition of Full Replicate Achievwin 2023-03-27 19:08
        
        Full Replicate with 3 periods mittyri 2023-03-27 22:16
        
        Full Replicate with 3 periods Achievwin 2023-03-28 03:06
        Full Replicate with 3 periods Helmut 2023-03-28 09:03
- Definition of Full ReplicateBrus 2023-03-14 10:10
- Replicate Design ≠ Higher-Order Crossover Helmut 2023-03-14 10:37
  - Thank You! Sereng 2023-03-14 20:08
  - Replicate Design ≠ Higher-Order Crossover Relaxation 2023-03-20 08:56
    - imbalance in Latin Square mittyri 2023-03-27 23:01