Bioequivalence and Bioavailability Forum • Proposed changes

Proposed changes [Two-Stage / GS Designs]

posted by Mauricio Sampaio – Brazil, 2020-02-17 14:50 (1075 d 06:45 ago) – Posting: # 21177
Views: 4,716

❝ Consequences for the Consulta Pública N° 760.

Instead of: "Type I error must be preserved and adjusted, and to demonstrate bioequivalence the level of confidence is 94.12%;"

I will only propose that: It must be demonstrated that the type I error of the study is controlled.

Instead of: "This second group must have at least 50% of the previous group"

I will propose that: The number of participants in the second stage must be calculated based on the data extracted from the first stage. The calculation must be justified considering possible losses and / or dropouts observed in the first stage.

In this way, the dialogue is open and not restricted. = "on top of the wall"

[image]

Edit: Subject line changed; see also this post #2. [Helmut]

Complete thread:

ANVISA guidelines for two-stage design Mauricio Sampaio 2020-02-11 20:52 [Two-Stage / GS Designs]
- Brainless copy-and-paste-devil Helmut 2020-02-12 02:26
  - Brainless copy-and-paste-devil Mauricio Sampaio 2020-02-12 17:33
- ANVISA guidelines for two-stage design ElMaestro 2020-02-12 08:27
  - ANVISA guidelines for two-stage design nobody 2020-02-12 08:49
  - ANVISA guidelines for two-stage design Helmut 2020-02-12 13:12
  - ANVISA guidelines for two-stage design Mauricio Sampaio 2020-02-12 17:04
  - ANVISA guidelines for two-stage design Mauricio Sampaio 2020-02-12 17:11
- ANVISA guidelines for two-stage design ElMaestro 2020-02-12 21:54
  - crap Helmut 2020-02-15 17:53
    - crap Mauricio Sampaio 2020-02-16 05:01
      - crap Helmut 2020-02-16 15:43
        
        crap d_labes 2020-02-16 19:34
        
        Explained crap remains crap Helmut 2020-02-17 12:49
        
        Proposed changesMauricio Sampaio 2020-02-17 13:50
        
        Proposed changes Helmut 2020-02-17 14:16