Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-05-21 09:16 UTC (UTC+2h)
 

Doesn't hurt! [Regulatives / Guidelines]

posted by VStus - Poland, 2017-03-23 13:24  - Posting: # 17180
Views: 7,541

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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
18,269 posts in 3,882 threads, 1,161 registered users;
19 users online (1 registered, 18 guests).

Science is wonderfully equipped to answer the question “How?”
but it gets terribly confused when you ask the question “Why?”    Erwin Chargaff

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed