X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 222 / 263

697 views

0 shares

0 downloads

0 comments

222 / 263

1

this particular generic product, therefore, was found to be bioequivalent to the reference product which in this case was the K-Dur microburst tablet.

For formulation B, the amount of potassium excreted in urine in 24 hours after dosing passed the 90 percent confidence interval criteria with or without the baseline correction.  However, as we've seen earlier, the 90 percent confidence interval was wider after baseline correction than for uncorrected data.

We also compared for formulation B two different ways of baseline correction for Rmax.  As previously, we compared the effect of subtracting the mean baseline from the 2 baseline days versus subtracting the mean baseline from the corresponding collection interval, and the test-to-reference ratios for Rmax were within the 90 percent confidence interval criteria whether corrected or uncorrected and regardless of which correction method was used.  However, as I've mentioned previously, the confidence intervals were wider when baseline correction was used.

So finally, to conclude, we have found that baseline correction is essential for evaluating

Document info
Document views697
Page views697
Page last viewedSat Dec 10 03:08:21 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments