RSABE… [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-02-24 14:46 (51 d 15:35 ago) – Posting: # 22228
Views: 668

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, :blahblah:) 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.

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Helmut Schütz

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