Bioequivalence and Bioavailability Forum • Cmax ER = Cmax IR

Cmax ER = Cmax IR - the only option [Regulatives / Guidelines]

posted by mittyri – Russia, 2019-12-06 16:08 – Posting: # 20946
Views: 938

Hi All,

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

Hmmm
the only option I see is something like this

t <- c(seq(0,24,0.1))

ka <- .5

ke <- 0.1

D = 100

V = 2

C <- D/V*(ka/(ka-ke))*(exp(-ke*t) - exp(-ka*t))

C[50] <- C[50]*10

ggplot2::qplot(t,C, geom = "line")

Could it be Mexico's reviewers ER vision?

—
Kind regards,
Mittyri

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 optionmittyri 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