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

posted by mittyri – Russia, 2019-12-06 17:08 (604 d 04:36 ago) – Posting: # 20946
Views: 2,117

Hi All,

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

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,

Complete thread:

 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Sunday 22:45 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz