title: A regulatory perspective on pharmacokinetic/pharmacodynamic modelling.
abstract: We present an integrated summary from statistical and pharmacological perspectives of pharmacokinetic/pharmacodynamic (PK/PD) modelling and its use in drug development and regulation for guiding appropriate dosing. An overview of the technical aspects of PK/PD modelling describes how structural models are constructed and refined using pharmacokinetic and pharmacodynamic principles and how random effects models are used to account for individual differences in desired (and undesired) responses due to patient characteristics. Lastly, we describe applications of PK/PD modelling for the purposes of drug labelling, for resolving a safety concern, and for improving therapeutic monitoring of anaesthetic depth during surgery.
authors.affiliation: Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857, USA. machados@cder.fda.gov
authors.forename: S G
authors.initials: SG
authors.lastname: Machado
authors.forename: R
authors.initials: R
authors.lastname: Miller
authors.forename: C
authors.initials: C
authors.lastname: Hu
mesh_terms: D001699:Biometry; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D015195:Drug Design; D006801:Humans; D007880:Legislation, Drug; D016015:Logistic Models; D008954:Models, Biological; D015233:Models, Statistical; D010599:Pharmacokinetics; D010600:Pharmacology; D012044:Regression Analysis