Bioequivalence and Bioavailability Forum • Cmax ER = Cmax IR ?

Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by jag009 – NJ, 2019-12-09 19:15 (1197 d 14:14 ago) – Posting: # 20967
Views: 2,273

Hi,

❝ We have: four maximums and four minimums for IR and one maximum and one minimum for ER

If I understand your question correctly... In general, your trough (Cmin) for ER should be similar (or above) your Cmin of the IR in terms of level (is your a 24hr once daily? If so, then the Cmin of ER at 24 should be similar to Cmin of IR at 24). Your ER should also show less fluctuation than IR (you should).

J

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