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RegisterRedosing study… [Study Assessment]
posted by Helmut 
– Vienna, Austria, 2011-06-16 14:52 (5483 d 02:30 ago) – Posting: # 7138
Views: 13,408
Dear Dan!
Should read ‘A redosing study may be acceptable for the FDA – but still they hate it.’
I’ve heard about this ‘method’ – do you have a reference? Assuming a normal distribution (after transformation) mean ±3SD covers 99.73% of the data. In other words, the sample size should be 370 in order to be able to ‘catch’ a single outlier.
Canada’s approaches are more reasonable, IMHO (cave: e.g., nonparametrics!).
❝ A redosing study is acceptable for the FDA […]
Should read ‘A redosing study may be acceptable for the FDA – but still they hate it.’
❝ Based on data from the pivotal study, an acceptance range for the ratios - mean ±3 standard deviations - should be calculated for AUC and Cmax using the log transformed data.
I’ve heard about this ‘method’ – do you have a reference? Assuming a normal distribution (after transformation) mean ±3SD covers 99.73% of the data. In other words, the sample size should be 370 in order to be able to ‘catch’ a single outlier.
Canada’s approaches are more reasonable, IMHO (cave: e.g., nonparametrics!).
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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:
- Redosing study… H.Patel 2011-06-15 16:28
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Redosing study… swapnil.kuche 2011-06-16 08:35
- Redosing study… Dr_Dan 2011-06-16 12:37
- Redosing study…Helmut 2011-06-16 12:52
- Redosing study… GSTATS 2011-06-16 16:12
- Redosing study… luvblooms 2011-06-17 06:34
- Redosing study… ElMaestro 2011-06-17 09:16
- Redosing study… luvblooms 2011-06-17 12:50
- Redosing study… ElMaestro 2011-06-17 13:09
- Redosing study… luvblooms 2011-06-18 11:47
- Redosing study… GSTATS 2011-06-17 16:57
- Redosing study… luvblooms 2011-06-18 11:53
- Redosing study… ElMaestro 2011-06-17 13:09
- Redosing study… luvblooms 2011-06-17 12:50
- Redosing study… ElMaestro 2011-06-17 09:16
- Redosing study… Dr_Dan 2011-06-16 12:37
- Redosing study… swapnil.kuche 2011-06-16 08:35
Ing. Helmut Schütz