small amount of the total.
In evaluating bioequivalence of potassium chloride oral dosage forms, we asked that firms calculate these parameters: the amount of potassium excreted in each collection interval, the cumulative excretion over 24 and 48 hours, the maximal rate of excretion, and the time of maximal excretion. We asked that firms report both the baseline and the uncorrected data, but the bioequivalence statistics are performed only on corrected data.
The key parameters for bioequivalence evaluation are the cumulative amount of potassium excreted in the 24-hour interval after dosing and Rmax, which is the maximal rate of excretion. The 90 percent confidence intervals for the ratios of test to reference must fall within the 80 to 125 percent goal posts.
We asked that baseline correction be subject- and period-specific. So in other words, what this means is that the amount excreted in the 24-hour interval after dosing in urine is corrected by subtracting the average amount excreted in 24 hours and determined during the two pre-dosing days.
Rmax, the maximal rate of excretion, is