PK/PD modelling and simulations: utility in drug development
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1Novartis Pharma AG, WSJ-210.6.29, CH-4056 Basel, Switzerland. iris.rajman@novartis.com
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.
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