Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-12-06 17:45  – Posting: # 20949
Views: 918

Hi John,

» » If you would succeed in demonstrating BE of Cmax you would have proven that your product is not an ER. Bizarre idea.
»
» Exactly. I am at a lost. I am not sure if the reviewer misread the protocol …

Might well be.

» … or he doesn't understand the concept.

Well,…

» Having said that (dont laugh), FDA once asked us to show BE for a 505b2 for an once day ER vs IR @ 4 hrs with respect to Cmax and AUC. It was v strange unless they are suspecting that Cmax is associated with efficacy (somehow).

Had that on this side of the pond as well (called a “hybrid application”); multiphasic product. Cmax was doable but only with expanded limits.

Cheers,
Helmut Schütz
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