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RegisterSample Size calculation and setting of BE limit base on Cmax or AUC [Power / Sample Size]
Dear all,
Please, advise on sample size estimation and setting of BE limits in the following situations where ISV for Cmax and AUC are far apart.
![[image]](img/uploaded/image446.png)
Greetings.
Please, advise on sample size estimation and setting of BE limits in the following situations where ISV for Cmax and AUC are far apart.
Greetings.
—
Mahmoud Teaima, PhD.
Mahmoud Teaima, PhD.
Complete thread:
- Sample Size calculation and setting of BE limit base on Cmax or AUCmahmoud-teaima 2017-05-22 13:55 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PK metric with largest variability – generally – drives the sample size Helmut 2017-05-22 15:16
- Regulatory guidance versus literature data mahmoud-teaima 2017-05-23 12:31
- FDA: If RSABE not recommended in product-specific guidance Helmut 2017-05-23 13:15
- FDA: If RSABE not recommended in product-specific guidance mahmoud-teaima 2017-05-23 16:20
- FDA: If RSABE not recommended in product-specific guidance Helmut 2017-05-23 13:15
- Regulatory guidance versus literature data mahmoud-teaima 2017-05-23 12:31
- PK metric with largest variability – generally – drives the sample size Helmut 2017-05-22 15:16
Ing. Helmut Schütz