Bioequivalence and Bioavailability Forum

override apples [Two-Stage / GS Designs]

posted by Astea – Russia, 2019-09-17 08:14 (2026 d 02:24 ago) – Posting: # 20605
Views: 13,237

Dear Helmut and Elena777!

❝ Why (see above)? Both AUC and C_max passed already in the first stage.

Oops, sorry . I was wrong (thought about the case of fail C_max). Thank you!

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 applesAstea 2019-09-17 06:14