Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-12-06 18:45 (1600 d 08:12 ago) – Posting: # 20949
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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.

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