SD vs. MD, partial AUCs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2013-06-21 21:24 (4040 d 05:17 ago) – Posting: # 10858
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Dear all,

some comments on this week’s workshop in Bonn.

»The BfArM still sleeping at 5 a.m.«

1. SD vs. MD

Status:Obviously the EMA does not trust in the empiric evidence of no problems in other countries (“absence of evidence is not evidence of absence”). The leap from ‘always’ to ‘never’ is not for cowards. Like in many other places the drafting party followed Canada’s rules, but not without tightening the thumbscrews.
As Alfredo García-Arieta pointed out “The 10% residual AUC are arbitrary; we could have used 20% or 5% as well.” OK, Canada is successfully applying the 20% for more than two decades [sic] now…
I love arbitrary values.

The suggested procedure starting with the SD study is as following:Now it is up to us to challenge the 90% criterion (empiric evidence from Canada). Furthermore, BE of Cτ makes sense, IMHO. Will be a tough job to convince Alfredo García-Arieta claiming: “I don’t believe in simulations.”

He was asked how achievement of steady state can be demonstrated and whether a statistical test is required. The answer was “A test is not expected. Reporting of pre-dose concentrations and plots are sufficient.” All other members of the drafting party nodded in agreement.

2. partialAUC (if applicable)

Status:There was a short discussion whether for delayed release AUC0-T & AUCT-t and for prolonged release AUC0-T & AUCT-∞ would be sufficient (dropping the respective other AUC-metrics). No consensus was reached.

Presentations of the workshop will be available for some limited time in a couple of weeks at EUFEPS’ website.

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