Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-12-06 16:41  – Posting: # 20945
Views: 951

Hi John,

» […] 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.
»
» I received a comment from the mexico regulatory when they reviewed the protocol. They wanted Cmax as an equivalent criteria as well …

What‽ If you would succeed in demonstrating BE of Cmax you would have proven that your product is not an ER. Bizarre idea.

Cheers,
Helmut Schütz
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