terminology [Power / Sample Size]
Hi Darya,
Like in this thread it is a question of terminology; see this thread for details.
In
Nitpick: Chaos everywhere. We have only sw – which is the estimate of the unknown σw…
BTW, when it comes to reference-scaling, both the EMA and the FDA correctly use swR. Since scaling is based on the unknown parameters, we might observe an inflation of the type I error.2
❝ You are wrote about converting the standard deviation to СV, but use the formula to convert the standard error to СV. I thought that the standard deviation and standard error are different parameters.
Like in this thread it is a question of terminology; see this thread for details.
In
PowerTOST
type ?se2CV
to get the formulas for conversion. If you want a second opinion:1Nitpick: Chaos everywhere. We have only sw – which is the estimate of the unknown σw…
BTW, when it comes to reference-scaling, both the EMA and the FDA correctly use swR. Since scaling is based on the unknown parameters, we might observe an inflation of the type I error.2
- Patterson S, Jones B. Bioequivalence and Statistics in Clinical Pharmacology. Boca Raton: Chapman & Hall / CRC; 2nd ed. 2016: p.47.
- Labes D, Schütz H. Inflation of Type I Error in the Evaluation of Scaled Average Bioequivalence, and a Method for its Control. Pharm Res. 2016;33(11):2805–14. doi:10.1007/s11095-016-2006-1. full text view-only.
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![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
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Complete thread:
- sample size in bioequivalence studies daryazyatina 2017-08-03 09:34 [Power / Sample Size]
- sample size in bioequivalence studies BE-proff 2017-08-03 09:55
- sample size in bioequivalence studies daryazyatina 2017-08-03 10:08
- sample size in bioequivalence studies ElMaestro 2017-08-03 10:17
- sample size in bioequivalence studies daryazyatina 2017-08-03 10:58
- sample size in bioequivalence studies DavidManteigas 2017-08-03 12:40
- sample size in bioequivalence studies daryazyatina 2017-08-03 13:46
- Don’t use the formula by Chow, Shao, Wang! Helmut 2017-08-03 15:37
- Don’t use the formula by Chow, Shao, Wang! daryazyatina 2017-08-03 15:52
- Don’t use the formula by Chow, Shao, Wang! DavidManteigas 2017-08-03 16:12
- Don’t use the formula by Chow, Shao, Wang! Helmut 2017-08-03 16:33
- Don’t use the Book by Chow, Shao, Wang! d_labes 2017-08-16 16:01
- compromised power Helmut 2017-08-03 16:04
- compromised power daryazyatina 2017-08-04 08:15
- terminologyHelmut 2017-08-04 12:41
- terminology daryazyatina 2017-08-16 10:12
- terminology Helmut 2017-08-16 18:54
- terminology daryazyatina 2017-08-16 10:12
- terminologyHelmut 2017-08-04 12:41
- compromised power daryazyatina 2017-08-04 08:15
- sample size in bioequivalence studies DavidManteigas 2017-08-03 12:40
- sample size in bioequivalence studies daryazyatina 2017-08-03 10:58
- sample size in bioequivalence studies balinskyi 2018-06-03 12:58
- sample size in bioequivalence studies BE-proff 2017-08-03 09:55