RSABE… [Regulatives / Guidelines]
Hi Loky do,
» Regarding AUC widening, is it applicable in both partially and fully replicate designs …
If the main condition for RSABE is fulfilled (high variabilty), yes. Contrary to jurisdictions applying ABEL, a clinical justification and assessment of ‘outliers’ is not required.
In RSABE you don’t ‘widen’ the limits. That’s a simplification. For the background see this post and the guidance you mentioned.
» … or fully replicate design only as FDA referred to the published book chapter for RSABE
Which book are you referring to?
» So could we apply it in general or it’s not applicable?
For the FDA you can apply RSABE for any PK metric (AUCs, partial AUCs, Cmax,
) if its \(\small{s_{\textrm{wR}}^{2}\geq 0.294\;(CV_{\textrm{wR}}\geq\approx0.300469\ldots)}\)
If \(\small{s_{\textrm{wR}}^{2}<0.294}\) you have to evaluate the respective PK metric for ABE.
» Regarding AUC widening, is it applicable in both partially and fully replicate designs …
If the main condition for RSABE is fulfilled (high variabilty), yes. Contrary to jurisdictions applying ABEL, a clinical justification and assessment of ‘outliers’ is not required.
In RSABE you don’t ‘widen’ the limits. That’s a simplification. For the background see this post and the guidance you mentioned.
» … or fully replicate design only as FDA referred to the published book chapter for RSABE
Which book are you referring to?
» So could we apply it in general or it’s not applicable?
For the FDA you can apply RSABE for any PK metric (AUCs, partial AUCs, Cmax,

If \(\small{s_{\textrm{wR}}^{2}<0.294}\) you have to evaluate the respective PK metric for ABE.
—
Dif-tor heh smusma 🖖
Helmut Schütz
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Dif-tor heh smusma 🖖
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Scaling/Widening of AUC Researcher101 2021-02-23 20:40 [Regulatives / Guidelines]
- 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