Bioequivalence and Bioavailability Forum • overripe apples

overripe apples [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2019-09-17 01:37 (1673 d 17:43 ago) – Posting: # 20604
Views: 8,482

Hi Nastia,

❝ ❝ […] BE criterion was met for AUC using α=0,05 (90%CI) and BE criterion was met for Cmax using α=0,0294 (94,12% CI). Does it look OK?

❝

❝ In this situation we still have to go to the next stage.

Why (see above)? Both AUC and C_max passed already in the first stage.

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Helmut Schütz

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Complete thread:

Appropriate wording for a protocol Elena777 2019-09-09 19:34 [Two-Stage / GS Designs]
- 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/C Helmut 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 applesHelmut 2019-09-16 23:37
        
        override apples Astea 2019-09-17 06:14