STRATEGY
Model-Informed Drug Development (MIDD) EMA's Advancement
Modelling and simulation (M&S) plays a crucial role in drug development. It allows information from diverse sources – pre-clinical and in-vitro data, early and late-stage clinical trial data, biomarkers, and efficacy outcomes – to be included with a dataset. Modelling enables researchers to visualize complex scenarios and determine what will happen if a parameter is changed in a clinical trial. It can optimize clinical study design, enable unnecessary studies to be waived, and inform risk: benefits in “what if” scenarios with specific patient populations or drug-drug interactions (DDI).
Eva Gil Berglund
Modelling & Simulation
Senior Director in Clinical Pharmacology and Regulatory Strategy, Certara
M&S is used in all phases of drug development in the EU, US, and UK starting from pre-clinical pharmacokinetic (PK) and pharmacokinetic/pharmacodynamics (PK/PD) studies, through clinical trials to post-marketing commitments. It is generally used to support the clinical pharmacology files and labelling for new drug applications. M&S supports early dose selection
Justin Hay Senior Director, Certara
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P H AR M A F O C U S E U R O PE
ISSUE 01 - 2022
