Bioequivalence and Bioavailability Forum • Inflation of the TIE as well

Inflation of the TIE as well [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2020-01-29 16:38 (1692 d 23:09 ago) – Posting: # 21095
Views: 21,434

Hi Elena,

you are modifying the common decision scheme. Why?
Since you are making essentially the same decisions though in a different order, you gain nothing.

❝ And another question: is this obligatory to include the detailed description of null and alternative hypotheses for Cmax (ABEL) and AUCt (ABE) together with description of conditions that lead to acceptance/rejection of a hypothesis in a protocol of a full replicate study?

Well, that’s the problem with ABEL (and the FDA’s RSABE as well). There is no Null Hypothesis. Before you assess the data you have no clue which path(s) of the framework you will follow. You can – and should – only describe the procedure.

—
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Helmut Schütz

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Complete thread:

Statistical evaluation and BE hypotheses in full replicate design Elena777 2020-01-28 07:02 [RSABE / ABEL]
- Inflation of the TIE as wellHelmut 2020-01-29 15:38
  - Inflation of the TIE as well Elena777 2020-01-29 20:01
    - Tricky… Helmut 2020-01-30 12:07
      - Tricky… Mikalai 2020-01-30 13:08
        
        Terrible… Helmut 2020-01-30 15:09
        
        Tricky… Mikalai 2020-01-30 16:02
        
        Deep shit Helmut 2020-01-30 16:59
        
        Deep shit Mikalai 2020-01-30 18:39
        
        Deep shit Mikalai 2020-01-30 19:31
        Deep shit Helmut 2020-01-30 20:07
        
        Deep shit Mikalai 2020-01-31 11:14
        
        Deep shit Helmut 2020-01-31 14:00
        
        Deep shit Mikalai 2020-01-31 16:07
        
        Flawed evaluation accepted Helmut 2020-01-31 12:19
        
        Flawed evaluation accepted Mikalai 2020-01-31 12:40
        
        Flawed evaluation accepted Helmut 2020-01-31 14:17
        
        Flawed evaluation accepted Mikalai 2020-01-31 16:41
        
        Flawed approach even if accepted ? Helmut 2020-01-31 20:28
        
        Flawed approach even if accepted ? Mikalai 2020-02-01 16:18
        
        misunderstanding mittyri 2020-02-01 21:34
        
        misunderstanding Mikalai 2020-02-06 13:41
        
        misunderstanding mittyri 2020-02-06 16:23
        
        The globe is flat! d_labes 2020-02-05 19:16
      - Tricky… wienui 2020-01-30 18:53
        
        Tricky… Helmut 2020-01-30 19:18
        
        Tricky… wienui 2020-02-03 07:10
        
        ABE vs. ABEL Helmut 2020-02-03 12:25
        
        zigzag d_labes 2020-02-05 18:53
        
        zigzag Helmut 2020-02-05 19:46
        
        zigzag Mikalai 2020-02-06 11:38
        
        helter-skelter Helmut 2020-02-06 20:12
        
        helter-skelter Mikalai 2020-02-10 16:10
  - Inflation of the TIE as well zizou 2020-02-01 17:00
    - Inflation of the TIE as well nobody 2020-02-01 23:30
  - Inflation of the TIE as well Elena777 2020-03-10 19:28
    - Fishing in the dark Helmut 2020-03-10 21:06
- Statistical evaluation and BE hypotheses in full replicate design nobody 2020-02-03 15:07
  - TIE, repeat once more please... Astea 2020-04-02 12:41