Bioequivalence and Bioavailability Forum • Cmax ER = Cmax IR ?

Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by jag009 – NJ, 2019-12-06 22:21 (2386 d 00:00 ago) – Posting: # 20950
Views: 5,519

Hi Helmut (and guys and girls)

❝ 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.

Do you know of any articles which say that Cmax is not a primary parameter (for equivalence) for ER product, when compared to IR?

Thx
john

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

Admin contact
23,654 posts in 4,992 threads, 1,570 registered users;
249 visitors (0 registered, 249 guests [including 101 identified bots]).
Forum time: 23:21 CEST (Europe/Vienna)

“Data! Data! Data!” he cried impatiently.
“I can’t make bricks without clay!” Arthur Conan Doyle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz