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Dear Byung-Ju,
have a look at the EMA Public Assessment Reports to be found here for another source of CV's for your sample size estimation. Unfortunately there are only 90% confidence intervals given.
But with a little math as explained in Helmut's lectures (f.i. this one) you will get the ISCV's.
A hint: If you can use R have a look at the package PowerTOST which will free you from the burden to do the math by paper and pencil (function CVfromCI()).
If you look at the resulting CV's from the studies mentioned in the PAR's you will find that at least for Cmax for studies in fed state there is the danger of having a CV >30% which is by convention seen as highly variable.
See for instance the PAR for the application of Wockhard Ltd. which gives for Cmax CV=34.8% in fasting state and CV=59.3% in fed state. Note the replicate design of the fed study.
Since there are a number of PARs its time to read Helmut's lectures with respect to pooling of CVs. No simple mean, median!
Hope this helps.
have a look at the EMA Public Assessment Reports to be found here for another source of CV's for your sample size estimation. Unfortunately there are only 90% confidence intervals given.
But with a little math as explained in Helmut's lectures (f.i. this one) you will get the ISCV's.
A hint: If you can use R have a look at the package PowerTOST which will free you from the burden to do the math by paper and pencil (function CVfromCI()).
If you look at the resulting CV's from the studies mentioned in the PAR's you will find that at least for Cmax for studies in fed state there is the danger of having a CV >30% which is by convention seen as highly variable.
See for instance the PAR for the application of Wockhard Ltd. which gives for Cmax CV=34.8% in fasting state and CV=59.3% in fed state. Note the replicate design of the fed study.
Since there are a number of PARs its time to read Helmut's lectures with respect to pooling of CVs. No simple mean, median!
Hope this helps.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- How is the calculated Sample Size? bjkim97 2010-12-22 02:42 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
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- How is the calculated Sample Size? VRP 2010-12-22 06:54
- How is the calculated Sample Size? bjkim97 2010-12-22 07:40
- How is the calculated Sample Size? boonchai_l 2010-12-22 09:06
- How is the calculated Sample Size? Dr_Dan 2010-12-22 11:06
- HVDs/HVDPs: global harmonization?! Helmut 2010-12-22 16:59
- How is the calculated Sample Size? boonchai_l 2010-12-22 09:06
- Pantoprazole CVsd_labes 2010-12-22 12:05
- Pantoprazole CVs boonchai_l 2010-12-22 21:26
- Expectation ElMaestro 2010-12-22 22:22
- Opinions Ohlbe 2010-12-23 01:23
- Pooling... Helmut 2010-12-23 15:29
- Choosing CVs d_labes 2011-01-03 08:43
- Pantoprazole CVs bjkim97 2010-12-23 14:43
- Pooling: example Helmut 2010-12-23 16:11
- Pantoprazole CVs boonchai_l 2010-12-22 21:26
- How is the calculated Sample Size? boonchai_l 2010-12-22 05:55
Ing. Helmut Schütz