Bioequivalence and Bioavailability Forum • Wrong answer

Wrong answer [General Statistics]

posted by Helmut – Vienna, Austria, 2023-10-06 09:19 (343 d 11:16 ago) – Posting: # 23745
Views: 3,107

Hi Mittyri & Achievewin,

❝ 15-20 years ago the answers could be the following

Speaking from a regulatory perspective since 23 years (the EMA Guideline) wrong.

❝ 6. How to factor or apply any corrections of observed carry-over in BE and RSABE calculations?

❝ Apply BE for the 1st period only.

Proven to be wrong in 1989.*

Freeman PR. The performance of the two-stage analysis of two-treatment, two-period cross-over trials. Stat Med. 1989; 8(12): 1421–32. doi:10.1002/sim.4780081202.

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Complete thread:

Carry over and statistical adjustment in BE computations Achievwin 2023-10-02 20:34 [General Statistics]
- Carry-over → 🚮 Helmut 2023-10-02 21:06
  - Carry-over → 🚮 Achievwin 2023-10-03 12:13
    - Carry-over → 🚮 Helmut 2023-10-03 12:48
    - Carry-over dshah 2023-10-03 16:34
      - Carry-over Achievwin 2023-10-03 20:33
        
        Carry-over Helmut 2023-10-04 08:31
        
        Carry-over Achievwin 2023-10-04 16:38
        
        Carry-over dshah 2023-10-04 11:22
      - more than 20% subject carry over effect investigation mittyri 2023-10-05 20:15
      - carry over effect investigation based on what? Helmut 2023-10-06 07:08
        
        carry over effect investigation based on what? dshah 2023-10-06 13:20
- Outdated and wrong answers mittyri 2023-10-05 20:34
  - Wrong answerHelmut 2023-10-06 07:19

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