Bioequivalence and Bioavailability Forum

Proposed changes [Two-Stage / GS Designs]

posted by Mauricio Sampaio  – Brazil, 2020-02-17 13:50 (529 d 13:03 ago) – Posting: # 21177
Views: 3,762

» 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"

---

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