Bioequivalence and Bioavailability Forum

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

posted by ElMaestro  – Denmark, 2020-02-12 09:27 (1135 d 09:05 ago) – Posting: # 21162
Views: 5,229

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????

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