X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 182 / 263

641 views

0 shares

0 downloads

0 comments

182 / 263

1

studies that comes from the diet.

So the urinary data that we collect also has to be adjusted for baseline and that baseline potassium that it has to be corrected for is basically what you gave in the food during the study.  So you still are facing baseline correction in the urinary data for potassium as well, and as I drew it here, although it's definitely not to scale, if you look at the blood concentrations, you're dealing with a much, much higher baseline than my previous illustration and that makes the blood more or less unsuitable for this particular bioequivalence procedure.

Again, I was going to just like pass over this slide quickly, but I again notice some people who didn't seem to understand the criteria that we used for bioequivalence, especially this last one, 90 percent confidence intervals must fit between 80 and 125.  There's a given misconception in the community that bioequivalence of 80 to 125 allows the mean data of a comparison between two products to vary between 80 and 125 percent.  That's absolutely not true.  That's a misunderstanding of the criteria.

What we're dealing with is the confidence

Document info
Document views641
Page views641
Page last viewedThu Dec 08 04:54:41 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments