Which country? [Two-Stage / GS Designs]
Dear Helmut and ElMaestro,
Thank you very much for responding me shortly. We are planning to submit applications in Belarus (the country I`m from) and in Russia. Hope method C will be OK for them.
Another 2 questions:
Thank you very much for responding me shortly. We are planning to submit applications in Belarus (the country I`m from) and in Russia. Hope method C will be OK for them.
Another 2 questions:
- Is it a good idea to add the statement that, in case of conducting stage 2, data from both stages will be pooled by default, without evaluation of differences between stages?
- Is there any established minimum for a number of subjects that should be included in stage 2 (e.g. at least 2, or at least 1 for each sequence (TR/RT))?
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
- The omniscient oracle has spoken Astea 2019-09-17 20:34
- The omniscient oracle has spoken Helmut 2019-09-17 12:27
- 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
- Use data of all dosed subjects Elena777 2019-09-19 15:27
- Use data of all dosed subjects Helmut 2019-09-19 15:16
- AUC passes with 0.05 and Cmax with 0.0294 Mikalai 2019-09-18 16:56
- AUC passes with 0.05 and Cmax with 0.0294 Helmut 2019-09-16 23:30
- Q&A ref Astea 2019-09-16 18:28
- 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
- overripe apples Helmut 2019-09-16 23:37
- apple tree for two-stage Astea 2019-09-16 20:39
- n2 based on PK metric with higher CV Helmut 2019-09-16 11:50
- EEU-rules, TSD-methods (lengthy question) Astea 2019-09-14 14:56
- EEU-rules, TSD-methods (lengthy answer) Helmut 2019-09-12 01:31
- Which country?Elena777 2019-09-11 20:24
- Appropriate wording for a protocol ElMaestro 2019-09-09 21:39