Bioequivalence and Bioavailability Forum • Hypotheses

Hypotheses [Outliers]

posted by Helmut – Vienna, Austria, 2021-06-19 14:32 (1314 d 21:13 ago) – Posting: # 22423
Views: 6,701

Hi Loky do,

in addition to what Mittyri and Dr Gunasakaran wrote, a general remark about confirmatory studies:

You state a null hypothesis H₀ and an alternative hypothesis H₁.
In bioequivalence H₀ is inequivalence – which you desire to reject.
You state an appropriate statistical method, most commonly the confidence inclusion approach.
You perform the study and assess #1 by #2.
The outcome is dichotomous, i.e., either the study passed (H₀ rejected) or it failed (H₀ not rejected).

What you must not do: The study failed according to the planned conditions and then you change #1 and/or #2 in order to make it pass. That’s the cherry-picking Mittyri was talking about.
In simple terms: The entire \({\small{\alpha=0.05}}\) was already ‘spent’ in the original analysis. Hence, any ‘alternative’ evaluation will increase the patient’s risk, which is not acceptable.

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Helmut Schütz

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Complete thread:

Outlier in fully replicate BE study Loky do 2021-06-16 00:49 [Outliers]
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
  - Widening for clopidogrel BE study Loky do 2021-06-16 15:38
    - Widening for clopidogrel BE study mittyri 2021-06-16 16:04
      - Widening for clopidogrel BE study Loky do 2021-06-16 17:08
        
        Widening for clopidogrel BE study - cherry-picking? mittyri 2021-06-16 17:27
        Widening for clopidogrel BE study drgunasakaran1 2021-06-17 12:01
        HypothesesHelmut 2021-06-19 12:32
        
        Hypotheses Loky do 2021-07-06 11:51
        
        ABEL ≠ RSABE Helmut 2021-07-06 16:17
        
        ABEL ≠ RSABE BEQool 2023-10-09 14:47
        
        power.TOST.sim and uncertainty mittyri 2023-10-11 12:42
        
        power.TOST.sim and uncertainty BEQool 2023-10-15 11:29
        
        power.TOST.sim and uncertainty mittyri 2023-10-20 21:47
        
        Distribution of PEs Helmut 2023-10-23 10:48
        
        Distribution of PEs BEQool 2023-10-23 19:55
        
        power.TOST.sim code mittyri 2023-10-31 15:40
        
        power.TOST.sim code BEQool 2023-11-02 11:22