correction to determine if the method of baseline correction made an impact on the outcome of the bioequivalence studies.
We recently revised and updated the guidance for industry on bioequivalence testing of potassium chloride products, and the web address is given here. The guidance describes recommendations for study design and emphasizes special dietary considerations to achieve a stable potassium baseline. The guidance also discusses collection of urine samples to evaluate pharmacokinetics and finally methods for data analysis.
To help in establishing a stable baseline that contributes minimally to the amount of potassium that we measure after giving a dose, we recommend that study subjects eat a diet with a controlled potassium intake. Normal potassium intake ranges from to 50 to 100 milliequivalents a day. Thus in these studies, the recommended potassium intake is on the low end of what's considered a normal diet for potassium intake. It's not really a low potassium diet or a diet deficient in potassium but rather a controlled potassium diet.
Fluids are given according to schedule.