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RegisterFDA: If RSABE not recommended in product-specific guidance [Power / Sample Size]
Salam Helmut,
Totally, agree with that.
Many thanks for advise.
Greetings.
Edit: Standard quotes restored; see also this post #8. [Helmut]
❝ submit the protocol for review anyway.
Totally, agree with that.
Many thanks for advise.
Greetings.
Edit: Standard quotes restored; see also this post #8. [Helmut]
—
Mahmoud Teaima, PhD.
Mahmoud Teaima, PhD.
Complete thread:
- Sample Size calculation and setting of BE limit base on Cmax or AUC mahmoud-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 guidancemahmoud-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