title: PK/PD modelling and simulations: utility in drug development.
abstract: Pharmacokinetic/pharmacodynamic (PK/PD) modelling and simulation can be used as an 'applied science' tool to provide answers on efficacy and safety of new drugs faster and at a lower cost. PK/PD modelling can be used from the preclinical phase through all clinical phases of drug development. Optimal use of PK/PD modelling and simulation will lead to fewer failed compounds, fewer study failures and smaller numbers of studies needed for registration. For PK/PD modelling to fulfil its potential in drug development, it needs to be embraced across the industry and regulatory agencies, and more education on this topic is required.
authors.affiliation: Novartis Pharma AG, WSJ-210.6.29, CH-4056 Basel, Switzerland. iris.rajman@novartis.com
authors.forename: Iris
authors.initials: I
authors.lastname: Rajman
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D003198:Computer Simulation; D015195:Drug Design; D004353:Drug Evaluation, Preclinical; D006801:Humans; D008954:Models, Biological; D010599:Pharmacokinetics; D010600:Pharmacology / Q000639:trends; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence / Q000379:methods