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.
Nedelman
J R
JR
Navartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Gibiansky
E
E
Cramer
J
J
Kovarik
J
J
Meligeni
J
J
Robbins
B
B
D000328:Adult; D000368:Aged; D001825:Body Fluid Compartments; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D006207:Half-Life; D006801:Humans; D008432:Mathematical Computing; D008875:Middle Aged; D008954:Models, Biological; D010599:Pharmacokinetics