Bioequivalence and Bioavailability Forum

‘Method C’ ⇒ risky [Two-Stage / GS Designs]

posted by Helmut  – Vienna, Austria, 2019-09-19 18:15 (1674 d 15:33 ago) – Posting: # 20622
Views: 8,169

Hi Elena,

❝ This is our first experience in conducting such studies, so we are quite excited.

Keep in mind that it might also be the first experience for the experts of the agencies you are aiming at. Possibly they have heard about the skeptic attitudes of European assessors towards ‘Method C’. Consider ‘Method B’ instead. See the end of this post for a comparison of power. What will it help to have (maybe) two subject less in the second stage and a study which is not accepted? I warned you.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• Appropriate wording for a protocol Elena777 2019-09-09 19:34 [Two-Stage / GS Designs] 
  • 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’ ⇒ riskyHelmut 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 apples Astea 2019-09-17 06:14