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Back to the forum  2018-07-22 07:25 CEST (UTC+2h)

Doesn't hurt! [Regulatives / Guidelines]

posted by VStus - Poland, 2017-03-23 14:24  - Posting: # 17180
Views: 8,487

Daer Helmut,
Dear Colleagues,

It even hurts less (or doesn't hurt at all) in case of scaled bioequivalence.
Last chunk of code modified:
CV  <- 0.42
#des <- "2x2x4"#scaled+mode subjects included for dro-outs
res <- sampleN.scABEL(CV=CV, design=des, print=FALSE)
n   <- res[["Sample size"]] + 8 #Let's assume we compensate for possible drop-outs
pwr <- res[["Achieved power"]]
wo  <- as.integer(substr(des, nchar(des), nchar(des)))-1
el  <- n
for (j in 1:wo) {
  el <- el*(1-dor/100)
}
cat("Study started with", n, "subjects (expected power",
    sprintf("%.1f%%).", 100*pwr),
    "\nStudy ended with", as.integer(el), "eligible subjects (expected power",
    sprintf("%.1f%%).", 100*power.scABEL(CV=CV, design=des, n=el, regulator='EMA')), "\n")

#Study started with 38 subjects (expected power 81.9%).
#Study ended with 32 eligible subjects (expected power 84.1%).


Best regards, VStus

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