Bioequivalence and Bioavailability Forum

Donald Schuirmann’s opinion [RSABE / ABEL]

posted by Helmut  – Vienna, Austria, 2018-04-10 16:41 (2001 d 04:34 ago) – Posting: # 18660
Views: 8,292

Hi BF,

see Donald Schuirmann’s presentation (starting at page 57). For the question whether the CI should include 1 (and his opinion), navigate to page 93.

R-code to reproduce his findings presented on page 94:
library(PowerTOST)
# only 1e5 sim's for speed!
# (1) pure scaled (without ABE and s-ratio)
n        <- seq(12, 48, 12)
GMR.min  <- 0.92
swR      <- 0.05
GMR      <- unique(sort(c(seq(GMR.min, 1/GMR.min, length.out=35), 1)))
res1     <- data.frame(GMR=GMR)
pwr.name <- paste0("pwr.", n)
res1[pwr.name] <- NA
col      <- c("darkblue", "magenta", "darkgreen", "red")
pch      <- c(18, 15, 17, 16)
for (j in seq_along(GMR)) {
  for (k in seq_along(n)) {
    res1[j, pwr.name[k]] <- power.NTIDFDA(theta0=GMR[j], CV=se2CV(swR), n=n[k],
                                          details=TRUE)[["p(BE-sABEc)"]]
  }
}
print(res1, row.names=FALSE)
op <- par(no.readonly=TRUE)
par(mar=c(3, 4, 2, 0) + 0.1)
split.screen(figs=c(2, 1))
screen(1)
main <- paste0("swR=swT=", swR, "\n\'pure\' NTID RSABE (without ABE and s-ratio)")
for (j in seq_along(n)) {
  pwr <- res1[[paste0("pwr.", n[j])]]
  if (j == 1) {
    plot(GMR, pwr, type="n", log="x", ylim=c(0, 1), ylab="power", las=1,
         cex.main=0.9, main=main)
    abline(h=c(0.05, seq(0, 1, 0.2)), lty=2, col="grey50")
    abline(v=1, lty=2, col="grey50")
  }
  points(GMR, pwr, col=col[j], pch=pch[j], cex=1.15)
  lines(GMR, pwr, col=col[j], lwd=2)
}
legend("bottomright", legend=c(paste("n =", n)), col=col, pch=pch,
       pt.cex=1.15, lwd=2, bg="white")
# (2) NTID-RSABE (with ABE and s-ratio)
res2     <- data.frame(GMR=GMR)
pwr.name <- paste0("pwr.", n)
res2[pwr.name] <- NA
for (j in seq_along(GMR)) {
  for (k in seq_along(n)) {
    res2[j, pwr.name[k]] <- power.NTIDFDA(theta0=GMR[j], CV=se2CV(swR), n=n[k],
                                          details=TRUE)[["p(BE)"]]
  }
}
print(res2, row.names=FALSE)
screen(2)
main <- paste0("swR=swT=", swR, "\nNTID RSABE (with ABE and s-ratio)")
for (j in seq_along(n)) {
  pwr <- res2[[paste0("pwr.", n[j])]]
  if (j == 1) {
    plot(GMR, pwr, type="n", log="x", ylim=c(0, 1), ylab="power", las=1,
         cex.main=0.9, main=main)
    abline(h=c(0.05, seq(0, 1, 0.2)), lty=2, col="grey50")
    abline(v=1, lty=2, col="grey50")
  }
  points(GMR, pwr, col=col[j], pch=pch[j], cex=1.15)
  lines(GMR, pwr, col=col[j], lwd=2)
}
legend("bottomright", legend=c(paste("n =", n)), col=col, pch=pch,
       pt.cex=1.15, lwd=2, bg="white")
close.screen(all=TRUE)
par(op)

❝ The point is, at Swr of .22, if you pass criteria 1, you generally pass criteria 2. Criteria 3 passes.

Yep. Run the code with
GMR.min <- 100/112
swR     <- 0.22

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 18:43 [RSABE / ABEL] 
  • [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:07
    • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 19:23
      • [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:44
        • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 20:05
          • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-28 21:25
            • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 21:59
              • [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 23:03
                • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 23:57
                  • Black Swan again mittyri 2018-04-05 17:57
  • [Opinion] Should the 90% CI for GMR be required to encompass 1 Helmut 2018-03-28 23:57
    • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 13:46
    • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 16:52
      • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 16:57
        • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 19:55
          • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 20:30
            • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 21:22
              • Paper & Presentations Helmut 2018-03-30 01:33
            • Donald Schuirmann’s opinionHelmut 2018-04-10 14:41