Background & Problem
The client asked us to evaluate the clinical consequences of exogenously administered calcium as part of a drug administered intravenously. Special attention was made for exogenous calcium administration in pediatric patients, patients with renal impairment, and the targeted patient population.
A physiologically-based model of calcium (Ca++) homeostasis from the literature was modified to account for varying weights, heights, estimated glomerular filtration rates (eGFR), variability in the baseline values of Ca++, intact parathyroid hormone (iPTH), calcitriol, and phosphorus along with difference in oral intake of Ca++ and phosphorus. Simulations were performed and an already approved drug containing calcium was used for comparison to evaluate the safety of the exogenously administered calcium.
The physiologically-based modeling and simulation approach was able to evaluate and confirm the safety of the exogenously administered calcium.