Log in
RegisterRSABE… [Regulatives / Guidelines]
Hi Dear Helmut,
Many thanks for your reply
» Which book are you referring to?
»
» For the FDA you can apply RSABE for any PK metric (AUCs, partial AUCs, Cmax,
) if its \(\small{s_{\textrm{wR}}\geq 0.294\;(CV_{\textrm{wR}}\geq\approx0.300469\ldots)}\)
» If \(\small{s_{\textrm{wR}}<0.294}\) you have to evaluate the respective PK metric for ABE.
I didn't find this statement in FDA guidance for bioequivalence studies just in progesterone guidance so, is it enough to refer to this guide while submitting the study to regulatory (as the intrasubject variability CV% equal 57%, partially replicate design), or is there another guide would support this way? please advice?
Thanks in advance
Many thanks for your reply
» Which book are you referring to?
»
» For the FDA you can apply RSABE for any PK metric (AUCs, partial AUCs, Cmax,
) if its \(\small{s_{\textrm{wR}}\geq 0.294\;(CV_{\textrm{wR}}\geq\approx0.300469\ldots)}\)» If \(\small{s_{\textrm{wR}}<0.294}\) you have to evaluate the respective PK metric for ABE.
I didn't find this statement in FDA guidance for bioequivalence studies just in progesterone guidance so, is it enough to refer to this guide while submitting the study to regulatory (as the intrasubject variability CV% equal 57%, partially replicate design), or is there another guide would support this way? please advice?
Thanks in advance
Complete thread:
- Scaling/Widening of AUC Researcher101 2021-02-23 20:40 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Scaling/Widening of AUC Loky do 2021-02-24 13:13
- Scaling/Widening of AUC Helmut 2021-02-24 15:29
- Scaling/Widening of AUC Loky do 2021-02-24 16:13
- Scaling/Widening of AUC dshah 2021-03-16 06:39
- Scaling/Widening of AUC Helmut 2021-03-16 13:55
Ing. Helmut Schütz