Bioequivalence and Bioavailability Forum • Cmax ER = Cmax IR ?

Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2019-12-06 15:41 (412 d 13:58 ago) – Posting: # 20945
Views: 1,944

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 C_max you would have proven that your product is not an ER. Bizarre idea.

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Complete thread:

NDA study for Mexico jag009 2019-12-06 16:19 [Regulatives / Guidelines]
- Cmax ER = Cmax IR ?Helmut 2019-12-06 16:41
  - Cmax ER = Cmax IR - the only option mittyri 2019-12-06 17:08
    - Cmax ER = Cmax IR - the only option Helmut 2019-12-06 17:36
  - Cmax ER = Cmax IR ? jag009 2019-12-06 17:38
    - Cmax ER = Cmax IR ? Helmut 2019-12-06 17:45
      - Cmax ER = Cmax IR ? jag009 2019-12-06 21:21
        
        Cmax ER = Cmax IR ? Yura 2019-12-06 22:40
        
        Cmax ER = Cmax IR ? jag009 2019-12-09 18:15