Sample 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.
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
- 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