Bioequivalence and Bioavailability Forum • Hybrid B/C

Hybrid B/C [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2019-09-18 19:09 (2115 d 20:29 ago) – Posting: # 20612
Views: 13,633

Dear Mikalai,

❝ What prevents us from evaluating the bioequivalence at α-level of 5% as the first step, and if we pass the bioequivalence criteria, we stop the trial. If we fail, we then evaluate the power. If power is more than 80% for the failed parameter, we stop the trial and we are done. If power is less than 80% for the failed parameter, then we go the next stage and adust α-level correspondingly to preserve overall α-level at 0,5. Of course, this should be written in the protocol and is a deviation, maybe a big one, from Potvin C method.

That’s more or less a hybrid of Method C (where you asses power first) and Method B (where you assess power after). You are free to develop such a method but have to validate it (i.e., find a suitable adjusted α which controls the type I error in every possible combination of n₁/CV).

—
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Helmut Schütz

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Complete thread:

Appropriate wording for a protocol Elena777 2019-09-09 19:34
- Appropriate wording for a protocol ElMaestro 2019-09-09 21:39
  - Appropriate wording for a protocol Helmut 2019-09-09 23:27
  - Appropriate wording for a protocol Ohlbe 2019-09-10 10:27
- Which country? Helmut 2019-09-09 23:17
  - Which country? Elena777 2019-09-11 20:24
    - EEU-rules, TSD-methods (lengthy answer) Helmut 2019-09-12 01:31
      - EEU-rules, TSD-methods (lengthy question) Astea 2019-09-14 14:56
        
        n2 based on PK metric with higher CV Helmut 2019-09-16 11:50
        
        Q&A ref Astea 2019-09-16 18:28
        
        The omniscient oracle has spoken Helmut 2019-09-17 12:27
        
        The omniscient oracle has spoken Astea 2019-09-17 20:34
        
        OT: Булга́ков Helmut 2019-09-18 12:12
        
        n2 based on PK metric with higher CV Elena777 2019-09-16 19:48
        
        AUC passes with 0.05 and Cmax with 0.0294 Helmut 2019-09-16 23:30
        
        AUC passes with 0.05 and Cmax with 0.0294 Mikalai 2019-09-18 16:56
        
        Hybrid B/CHelmut 2019-09-18 17:09
        
        AUC passes with 0.05 and Cmax with 0.0294 Elena777 2019-09-19 08:34
        
        Use data of all dosed subjects Helmut 2019-09-19 15:16
        
        Use data of all dosed subjects Elena777 2019-09-19 15:27
        
        ‘Method C’ ⇒ risky Helmut 2019-09-19 16:15
        
        EEU-rules, TSD-methods (lengthy question) Elena777 2019-09-16 19:35
        
        apple tree for two-stage Astea 2019-09-16 20:39
        
        overripe apples Helmut 2019-09-16 23:37
        
        override apples Astea 2019-09-17 06:14