Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-12-06 17:38 (521 d 15:13 ago) – Posting: # 20948
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» » […] a study comparing ER once a day vs IR given multi-times a days, e.g, ER vs IR given every 4 hours. When conducting such studies, the success criteria is based on equivalent AUC (90% CI), and not Cmax due to the nature of the ER drug release kinetic.
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» » I received a comment from the mexico regulatory when they reviewed the protocol. They wanted Cmax as an equivalent criteria as well …
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» What‽ 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 or he doesn't understand the concept. 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).

John

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