Bioequivalence and Bioavailability Forum • ANVISA guidelines for two-stage design

ANVISA guidelines for two-stage design [Two-Stage / GS Designs]

posted by ElMaestro – Belgium?, 2020-02-12 08:27 – Posting: # 21162
Views: 2,061

Hi MS,

» Art.75. For two-stage studies, the following should be noted: It is acceptable to use a two-stage approach to demonstrate bioequivalence based on ignorance of the intra-individual variability of the drug;

Ermmm...... WHAT???? :-D

—
This week's list of things I absolutely detest: Corona virus, the which function in R, WIA-WIA interfaces for scanning under Windows 10, the Bee Gees, the smell of my fridge.

Best regards,
ElMaestro

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 designElMaestro 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 changes Mauricio Sampaio 2020-02-17 13:50
        
        Proposed changes Helmut 2020-02-17 14:16