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Multiple-dose pharmacokinetics of a long half-life drug: contributions of mathematical modeling
J R Nedelman1, E Gibiansky, J Cramer
1Navartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
European Journal of Drug Metabolism and Pharmacokinetics
|April 1, 1997
Abstract:
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.