Bioequivalence and Bioavailability Forum

Appropriate wording for a protocol [Two-Stage / GS Designs]

posted by Elena777 – Belarus, 2019-09-09 19:34  – Posting: # 20564
Views: 2,328

Dear all, I would be pleased to get your opinion on the following. We are planning to conduct several BE studies with adaptive design using the drugs with uncertain intraCV. We have decided to use method C described by Potvin and included the description of the model C in the protocols (the same as in the corresponding scheme presented in Potvin's article). But it seems it's not enough.

1. Should we include the information that evaluation after stage 1 completion should be performed assuming GMR=0.95?
   
2. Should we describe the maximum number of subjects who can be included in whole or in stage 2?
   
3. Any other information that should be clearly stated in order to be accurate and to satisfy regulatory authorities?
   
4. What if BE criteria are met after stage 1, but estimated power is too low (e.g. 30%)?

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Post number 20,000.  [Helmut]

Complete thread:

• Appropriate wording for a protocolElena777 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’ ⇒ 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 apples Astea 2019-09-17 06:14