Bioequivalence and Bioavailability Forum

Lack of ISR / only 5% ISR in study with 656 samples [Regulatives / Guidelines]

posted by nobody – 2014-10-23 12:06 (3873 d 07:06 ago) – Posting: # 13775
Views: 11,132

❝ Next do this:

❝ for (i in 1:sims) {

❝   xboot = sample(data, replace=T)

❝   y      <- length(xboot[abs(xboot)>20]) # No. of abs. deviations > 20%

❝   y      <- y/ISR.no        # Fraction of repeats with > 20% deviation

❝   if (y > 1/3) failed <- failed + 1

❝ }

❝ cat(sprintf("%i",sims),"simulated studies with", size, "samples:\n",

❝   "Method: Bootstrapping (Mersenne-Twister) of ISR data\n",

❝   "Failed criterion (deviations >20% in >1/3 of repeats) seen in",

❝   sprintf("%.2f%% %s", 100*failed, "of studies.\n"))

Wanted to perform some kind of sensitivity analysis to see at which criterion studies start to fail. With 1/8 of samples deviating more than 20% I get 200% study failure, due to simply multiplying number of failed studies by 100 in the output, but should be divided by number of studies simulated, I guess. The code above works only as long as 0 trials fail, i guess

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post. [Helmut]
Of course, you are correct. The line should be:
  sprintf("%.2f%% %s", 100*failed/sims, "of studies.\n"))

Complete thread:

• Incurred sample reanalysis sarada06884 2013-04-09 12:22 [Regulatives / Guidelines] 
  • Incurred sample reanalysis Ohlbe 2013-04-09 14:09
    • Incurred sample reanalysis The Outlaw Torn 2013-04-10 08:40
      • Clopidogrel Ohlbe 2013-04-10 10:34
        • Clopidogrel The Outlaw Torn 2013-04-10 11:31
          • Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 17:01
            • Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-22 18:56
              • Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 19:35
                • "Meth" - apologies ElMaestro 2013-04-22 20:03
                  • "Meth" - apologies The Outlaw Torn 2013-04-23 08:27
                    • "Meth" - apologies ElMaestro 2013-04-23 14:29
                      • "ISR" - apologies The Outlaw Torn 2013-04-24 07:44
                        • Repeat use ElMaestro 2013-04-24 11:08
                          • Repeat use Ohlbe 2013-04-24 11:41
                            • Repeat use ElMaestro 2013-04-24 13:45
                        • "ISR" – resolved Helmut 2013-09-20 21:50
                          • "ISR" – resolved Dr_Dan 2013-09-22 16:56
            • Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-23 23:31
              • Some more stuff Helmut 2013-04-24 02:08
              • Lack of ISR / only 5% ISR in study with 656 samplesnobody 2014-10-23 10:06