Bioequivalence and Bioavailability Forum • Some more stuff

Some more stuff [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-04-24 04:08 (4420 d 16:02 ago) – Posting: # 10481
Views: 14,718

Hi ElMaestro,

THX for your help over there. Now it looks even more nice (using the repeats’ % deviation):

data   <- c(-0.53, -3.19, -2.65, -2.77, -1.49, -1.12, +5.38, +0.45,

            -3.33, -2.51, -1.37, -5.49, +2.22, -1.77, -4.42, -3.69,

            -4.18, +5.57, -2.03, -7.79, +1.02, -7.43, -1.67, +1.33,

            -3.40, +2.80, -1.24, +2.80, -5.85, +5.30, -2.00, -0.87)

mean   <- mean(data)/100    # Mean deviation

sd     <- sd(data)/100      # SD of deviations

❝ Run your code, then do shapiro.test(data) and discuss if the high p-value proves that the data are Gaussian.

Yessir!

        Shapiro-Wilk normality test



data:  data

W = 0.9624, p-value = 0.3184

I was already amazed yesterday by:

xfit <- seq(-max(abs(data))*1.25, max(abs(data))*1.25, length=50)

yfit <- dnorm(xfit, mean=mean*100, sd=sd*100)

hist(data, prob=TRUE, col="grey", main="ISR: deviation from means",

  xlim=c(min(xfit), max(xfit)), ylim=c(0, max(yfit)*1.25),

  las=1, xlab="% deviation")

lines(xfit, yfit, lwd=2, col="blue")

Haven’t thought about a formal test for normality!

Of course I can politely ask for the probability of getting a deviation of -20% or lower:

pnorm(-20, mean=mean*100, sd=sd*100)

[1] 2.115518e-08

Didn’t I fantasize about 6σ already?

What about a wacky setup in the spirit of Anderson & Hauck to get the probability of a result outside of [-20%, +20%]?

❝ Next do this: […]

I would rather bootstrap for 10% of the study’s samples based on the 5% I have …

xboot <- sample(data, size=ISR.no, replace=T)

… since I want to justify that based on the x/SD from 32 samples I will pass with the Dutch 66 as well.

❝ ...and argue that even when you do not make any assumption of ISR distribution you are still very clearly very far from any sort of trouble.

Yep.

—
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Helmut Schütz

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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 stuffHelmut 2013-04-24 02:08
        Lack of ISR / only 5% ISR in study with 656 samples nobody 2014-10-23 10:06