Bioequivalence and Bioavailability Forum • Appropriate wording for a protocol

Appropriate wording for a protocol [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2019-09-09 23:39 (2475 d 08:01 ago) – Posting: # 20565
Views: 19,504

Hello Elena777,

❝ 1. Should we include the information that evaluation after stage 1 completion should be performed assuming GMR=0.95?

I would do so.

❝ 2. Should we describe the maximum number of subjects who can be included in whole or in stage 2?

I would only put a cap on it if you can refer to simulations having done exactly so (having done so in exactly your way of capping).

❝ 3. Any other information that should be clearly stated in order to be accurate and to satisfy regulatory authorities?

Exact decision tree, and exact values for alphas, desired power level, and power being calculated using GMR=0.95.

❝ 4. What if BE criteria are met after stage 1, but estimated power is too low (e.g. 30%)?

"Too low"?
It is not a crime to be lucky. I don't see any issue. Regulators are generally not afraid of low power after results become available. This forum is a paradise for grumpy old men being adverse to post-hoc power. I used be to a reasonably happy, cheerful bloke, but then I got a profile here and quickly I went very sour if not outright angry. I blend in nicely, I think?!? :-D

—
Pass or fail!
ElMaestro

Complete thread:

Appropriate wording for a protocol Elena777 2019-09-09 19:34
- Appropriate wording for a protocolElMaestro 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 apples Helmut 2019-09-16 23:37
        
        override apples Astea 2019-09-17 06:14