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A regulatory perspective on pharmacokinetic/pharmacodynamic modellingOffice of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA, machados{at}cder.fda.gov
Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA
Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA 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.
Statistical Methods in Medical Research, Vol. 8, No. 3,
217-245 (1999) This article has been cited by other articles:
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