Bioequivalence and Bioavailability Forum • Cmax ER = Cmax IR ?

Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2019-12-06 18:45 (1202 d 23:26 ago) – Posting: # 20949
Views: 2,362

Hi John,

❝ ❝ If you would succeed in demonstrating BE of C_max 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. C_max was doable but only with expanded limits.

—
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Helmut Schütz

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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