Bioequivalence and Bioavailability Forum

Hi Beholder,

to set the paragraph you quoted into perspective, the preceding one:

“Association AIPM analyzed results of inspections of Russian and foreign sites. In 2015–2017, local manufacturers were issued 187 GMP certificates, the number of failures – zero.”

❝ “The situation with the inspection of foreign sites is diametrically opposite. In 2016-2017, 1167 applications were submitted to the Ministry of Industry and Trade, 589 inspections were carried out, 497 conclusions were issued. Almost 25% of manufactures were refused. The largest share of failures is accounted for manufactures located in Europe, »which, I emphasize, have been living for several decades in the regime of existence of regulatory requirements for production and inspection», Vladimir Shipkov commented.”

local    <- c(0, 187)
European <- c(124, 497-124)
GMP      <- matrix(c(local, European), nrow=2,
                   dimnames=list(guess=c("local", "European"),
                                 truth=c("local", "European")))
ft       <- fisher.test(GMP, alternative="less")
cat("Failures (%)",
    "\nEuropean:", sprintf("%4.1f%%",
       100*European[1]/sum(European)),
    "\nlocal   :",
       sprintf("%4.1f%%", 100*local[1]/sum(local)),
    "\n\n"); print(GMP); print(ft)

Failures (%)
European: 24.9%
local   :  0.0%

          truth
guess      local European
  local        0      124
  European   187      373

        Fisher's Exact Test for Count Data

data:  GMP
p-value < 2.2e-16
alternative hypothesis: true odds ratio is less than 1
95 percent confidence interval:
 0.00000000 0.04949719
sample estimates:
odds ratio
         0

❝ So, looks like the child is going to teach Daddy?

A likely story! SCNR.