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RegisterRegulatory guidance versus literature data [Power / Sample Size]
Salam Helmut,
Thank you for the detailed, evidence-proofed explanation.
The problem here is that literature data archiving the PKs and output of previous BE studies on simvastatin show border ISV with CV around 30% (29% - 33%).
On the contrary, till the moment, the FDA guidance for BE study on Simvastatin doesn't involve reference scaling
https://www.fda.gov/downloads/Drugs/.../Guidances/ucm086171.pdf
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm089636.pdf
So, the straightforward question is:
Does the BE study of Simvastatin involve reference scaling due the border ISV of simvastatin derived from literature though the regulator doesn't imply that?
Greetings.
Thank you for the detailed, evidence-proofed explanation.
The problem here is that literature data archiving the PKs and output of previous BE studies on simvastatin show border ISV with CV around 30% (29% - 33%).
On the contrary, till the moment, the FDA guidance for BE study on Simvastatin doesn't involve reference scaling
https://www.fda.gov/downloads/Drugs/.../Guidances/ucm086171.pdf
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm089636.pdf
So, the straightforward question is:
Does the BE study of Simvastatin involve reference scaling due the border ISV of simvastatin derived from literature though the regulator doesn't imply that?
Greetings.
—
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
![[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 datamahmoud-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 datamahmoud-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