Multiple-dose pharmacokinetics of a long half-life drug: contributions of mathematical modeling

A mathematical model was found that consistently described diverse pharmacokinetic data for a development compound from three pharmacokinetic studies in healthy volunteers and two efficacy and safety studies in patients. The model provided: quantification of demographic and random sources of pharmacokinetic variability; estimation of important pharmacokinetic parameters from sparse data; and explanation of observed patterns of pharmacokinetic response.