Bioequivalence and Bioavailability Forum • Which country?

Which country? [Two-Stage / GS Designs]

posted by Elena777 – Belarus, 2019-09-11 20:24 – Posting: # 20587
Views: 4,103

Dear Helmut and ElMaestro,

Thank you very much for responding me shortly. We are planning to submit applications in Belarus (the country I`m from) and in Russia. Hope method C will be OK for them.

Another 2 questions:

Is it a good idea to add the statement that, in case of conducting stage 2, data from both stages will be pooled by default, without evaluation of differences between stages?
Is there any established minimum for a number of subjects that should be included in stage 2 (e.g. at least 2, or at least 1 for each sequence (TR/RT))?

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/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