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RegisterDetermination of sample size including the factor of σD [Power / Sample Size]
Hello everybody,
In Table 1, Appendix C of FDA 2001 guidance Statistical Approaches to Establishing Bioequivalence, the sample size is calculated for different σDs. I was wondering how this is done? Nothing can I find in the two references listed with the talbe.
One further question, when power.RSABE() of R package TOST is used in simulation that gives sample size for RSABE design, does it account for σD, or the σD is assumed to be zero?
In a previous post, A reference is mentioned:
Scott D Patterson and Byron Jones
REPLICATE DESIGNS AND AVERAGE, INDIVIDUAL, AND POPULATION BIOEQUIVALENCE
GSK BDS Technical Report 2002 – 01
A link was given below but I failed opening it
. Can somebody help to try if this link is still correct?
http://biometrics.com/wp-content/uploads/2009/06/tr2002-01.pdf
Thank you,
Junhao//
In Table 1, Appendix C of FDA 2001 guidance Statistical Approaches to Establishing Bioequivalence, the sample size is calculated for different σDs. I was wondering how this is done? Nothing can I find in the two references listed with the talbe.
One further question, when power.RSABE() of R package TOST is used in simulation that gives sample size for RSABE design, does it account for σD, or the σD is assumed to be zero?
In a previous post, A reference is mentioned:
Scott D Patterson and Byron Jones
REPLICATE DESIGNS AND AVERAGE, INDIVIDUAL, AND POPULATION BIOEQUIVALENCE
GSK BDS Technical Report 2002 – 01
A link was given below but I failed opening it
. Can somebody help to try if this link is still correct?http://biometrics.com/wp-content/uploads/2009/06/tr2002-01.pdf
Thank you,
Junhao//
Complete thread:
- Determination of sample size including the factor of σDjunhao 2016-07-08 04:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample size taking into account SbF d_labes 2016-07-13 13:49
- Sample size taking into account SbF junhao 2016-07-14 05:54
- Sample size taking into account SbF d_labes 2016-07-19 09:18
- Appendix C, Table I Helmut 2016-07-19 15:07
- Appendix C, Table I d_labes 2016-07-20 11:27
- I don’t care Helmut 2016-07-20 15:45
- Appendix C, Table I d_labes 2016-07-20 11:27
- Appendix C, Table I Helmut 2016-07-19 15:07
- Sample size taking into account SbF d_labes 2016-07-19 09:18
- Sample size taking into account SbF junhao 2016-07-14 05:54
- Sample size taking into account SbF d_labes 2016-07-13 13:49
Ing. Helmut Schütz