RSABE… [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-02-24 15:46 (709 d 21:15 ago) – Posting: # 22228
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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 \(\small{s_{\textrm{wR}}\geq 0.294\;(CV_{\textrm{wR}}\geq\approx0.300469\ldots)}\)
If \(\small{s_{\textrm{wR}}<0.294}\) you have to evaluate the respective PK metric for ABE.

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