X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 221 / 263

622 views

0 shares

0 downloads

0 comments

221 / 263

1

of the two baseline correction methods we used.

This figure shows the potassium excretion rate plotted versus the midpoint of the collection interval time.  The upper plots are for uncorrected excretion rates after dosing for both the test and the reference.  The lower plots are the excretion rates pre-dosing.  The baseline excretion rate contributes about 20 to 30 percent of the total excretion rate.

This figure shows the potassium-excreted rate corrected for baseline, plotted against the midpoint of the post-dosing collection intervals and it's for the test product versus the reference product.  This is for formulation A, the product that did not pass bioequivalence criteria for Rmax, and you can see here that the differences in Rmax are more apparent after correcting for baseline than before correcting for baseline.

The second example that I'm going to present is also for a 20 milliequivalent extended release tablet product.  For this product, both the amount excreted in 24 hours in Rmax passed the 90 percent confidence interval criteria whether baseline correction was done or not and

Document info
Document views622
Page views622
Page last viewedWed Dec 07 16:30:33 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments