X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 86 / 263

665 views

0 shares

0 downloads

0 comments

86 / 263

1

producer risk.  So this is one of those "how's that possible" sorts of thing because normally in study design, you think of those two things as being trade-offs.  You can have difficulties doing both at the same time.

So first of all, this is actually the difference.  Again, this is now the 2001 criterion, first stage with an n of 24, so this is out of their report.  So the blue curve shows you what would be acceptable samples, based on a standard tolerance interval approach, and then the green curve is the IPAC-RS proposal.  You saw me put a limit on the sample standard deviation.  That's what puts the flat top.  In exchange for that, to maintain the 5 percent, they get to add some shoulders to the curve, and then the red lines, which hopefully show up, are the plus or minus 15 percent on the sample mean.

So how are they able to deliver?  So part of it's the parametric to nonparametric difference.  The parametric approach will give you lower producer risk for a given level of sample size and consumer risk.  So that's part of it.  The elimination of zero tolerance criterion is certainly part of it, and then I bolded the last one because one of the things that -- I don't know if you

Document info
Document views665
Page views665
Page last viewedFri Dec 09 02:08:09 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments