A regulatory perspective on pharmacokinetic/ pharmacodynamic modelling

We present an integrated summary from statistical and pharmacological persp ectives of pharmacokinetic/pharmacodynamic (PK/PD) modelling and its use in drug development and regulation for guiding appropriate dosing. An overvie w of the technical aspects of PK/PD modelling describes how structural mode ls are constructed and refined using pharmacokinetic and pharmacodynamic pr inciples and how random effects models are used to account for individual d ifferences in desired (and undesired) responses due to patient characterist ics. Lastly, we describe applications of PK/PD modelling for the purposes o f drug labelling, for resolving a safety concern, and for improving therape utic monitoring of anaesthetic depth during surgery.