Optimal Design of a Clinical Test for Measuring Glomerular Filtration Rate in Patients with Borderline Renal Function

摘要

The design of a bolus injection test for measuring glomerular filtration rate in patients with about 50% renal impairment is addressed. Pharmacokinetic parameters of potential test substances for this population of borderline patients are derived from available data collected in a general population using a compartmental modeling approach. The statistical distributions are used in Monte Carlo simulations for selecting the most suitable number of exponential terms necessary to describe plasma disappearance curves. Finally the optimal sampling schedule design is considered under different hypotheses of measurement noise variance. At the end this study provides useful information for the design of a pilot study that will eventually lead to a proposal of a clinically useful test.