Bioequivalence and Bioavailability Forum • Doesn't hurt!

Doesn't hurt! [Regulatives / Guidelines]

posted by VStus – Poland, 2017-03-23 15:24 (2587 d 18:05 ago) – Posting: # 17180
Views: 23,158

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:

Highly Variable Drug BE Justification jag009 2017-03-20 04:42 [Regulatives / Guidelines]
- Highly Variable Drug BE Justification ElMaestro 2017-03-20 06:55
  - Study costs: Replicate vs. 2×2×2 Helmut 2017-03-20 13:12
    - Study costs: Replicate seems to be cheaper VStus 2017-03-21 12:49
      - Study costs: Replicate seems to be cheaper Dr_Dan 2017-03-21 13:06
        
        Study costs: Replicate seems to be cheaper Helmut 2017-03-21 14:50
        
        expected power d_labes 2017-03-21 15:16
        Doesn't hurt!VStus 2017-03-23 14:24
    - Study costs: Replicate vs. 2×2×2 mahmoud-teaima 2017-03-23 08:17
    - Study costs: Replicate vs. 2×2×2 M.tareq 2017-05-07 21:21
      - Replicate vs. 2×2×2 (ethics?) Helmut 2017-05-08 14:21
        
        Replicate vs. 2×2×2 (ethics?) nobody 2017-05-08 14:52
        
        Applicability of reference-scaling Helmut 2017-05-10 14:10
        
        Replicate vs. 2×2×2 M.tareq 2017-05-14 23:04
        
        Replicate vs. 2×2×2 Helmut 2017-05-15 19:07
        
        Replicate vs. 2×2×2 M.tareq 2017-05-15 21:02
        Regulators view of HVD drugs DavidManteigas 2017-05-16 12:41
        
        Regulators view of HVD drugs Helmut 2017-05-16 15:01
        What's the problem? ElMaestro 2017-05-17 03:30
        
        What's the problem? nobody 2017-05-17 07:48
        
        What's the problem? nobody 2017-05-17 09:31
        
        What's the problem? DavidManteigas 2017-05-17 11:25
        
        What's the problem? ElMaestro 2017-05-17 12:07
        
        What's the problem? kumarnaidu 2017-07-11 14:43
        
        What's the problem? ElMaestro 2017-07-11 14:56