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

posted by mittyri  – Russia, 2019-12-06 18:08 (2044 d 17:26 ago) – Posting: # 20946
Views: 4,368

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.


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")

[image]
Could it be Mexico's reviewers ER vision?

Kind regards,
Mittyri

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