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RegisterWhat's the problem? [Regulatives / Guidelines]
Thank you all for your feedbacks.
It would be interesting to study the within study variation for the same compound in the same unit to understand which is the main source of variability. Although I understand the point of El Maestro about assay sensitivity, I don't think that could be pointed as a cause for a study which presented high variability when other studies reported low variability. I understand the approach to highly variable drugs, when the drug is actually highly variable per se and not due to study conduct or assay sensibility.
It would be interesting to study the within study variation for the same compound in the same unit to understand which is the main source of variability. Although I understand the point of El Maestro about assay sensitivity, I don't think that could be pointed as a cause for a study which presented high variability when other studies reported low variability. I understand the approach to highly variable drugs, when the drug is actually highly variable per se and not due to study conduct or assay sensibility.
Complete thread:
- Highly Variable Drug BE Justification jag009 2017-03-20 04:42 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Highly Variable Drug BE Justification ElMaestro 2017-03-20 06:55
- Study costs: Replicate vs. 2×2×2 Helmut 2017-03-20 13:12
- Study costs: Replicate seems to be cheaper VStus 2017-03-21 12:49
- Study costs: Replicate seems to be cheaper Dr_Dan 2017-03-21 13:06
- Study costs: Replicate seems to be cheaper Helmut 2017-03-21 14:50
- expected power d_labes 2017-03-21 15:16
- Doesn't hurt! VStus 2017-03-23 14:24
- Study costs: Replicate seems to be cheaper Helmut 2017-03-21 14:50
- Study costs: Replicate seems to be cheaper Dr_Dan 2017-03-21 13:06
- Study costs: Replicate vs. 2×2×2 mahmoud-teaima 2017-03-23 08:17
- Study costs: Replicate vs. 2×2×2 M.tareq 2017-05-07 21:21
- Replicate vs. 2×2×2 (ethics?) Helmut 2017-05-08 14:21
- Replicate vs. 2×2×2 (ethics?) nobody 2017-05-08 14:52
- Applicability of reference-scaling Helmut 2017-05-10 14:10
- Replicate vs. 2×2×2 M.tareq 2017-05-14 23:04
- Replicate vs. 2×2×2 Helmut 2017-05-15 19:07
- Replicate vs. 2×2×2 M.tareq 2017-05-15 21:02
- Regulators view of HVD drugs DavidManteigas 2017-05-16 12:41
- Regulators view of HVD drugs Helmut 2017-05-16 15:01
- What's the problem? ElMaestro 2017-05-17 03:30
- What's the problem? nobody 2017-05-17 07:48
- What's the problem? nobody 2017-05-17 09:31
- What's the problem?DavidManteigas 2017-05-17 11:25
- What's the problem? ElMaestro 2017-05-17 12:07
- What's the problem? kumarnaidu 2017-07-11 14:43
- What's the problem? ElMaestro 2017-07-11 14:56
- What's the problem? kumarnaidu 2017-07-11 14:43
- What's the problem? ElMaestro 2017-05-17 12:07
- What's the problem?DavidManteigas 2017-05-17 11:25
- What's the problem? nobody 2017-05-17 09:31
- What's the problem? nobody 2017-05-17 07:48
- Replicate vs. 2×2×2 Helmut 2017-05-15 19:07
- Replicate vs. 2×2×2 (ethics?) nobody 2017-05-08 14:52
- Replicate vs. 2×2×2 (ethics?) Helmut 2017-05-08 14:21
- Study costs: Replicate seems to be cheaper VStus 2017-03-21 12:49
- Study costs: Replicate vs. 2×2×2 Helmut 2017-03-20 13:12
- Highly Variable Drug BE Justification ElMaestro 2017-03-20 06:55
Ing. Helmut Schütz