Model-informed Drug Development Intensive Interactive Courses

Limited Availability on all Courses for 2021

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Incorporating population variability into mechanistic prediction of PK and modeling PK/PD The model-informed approach to various aspects of drug development is rapidly being adopted by the leading pharmaceutical companies. The Simcyp workshops focus on the optimal use of compound-specific in vitro and in vivo data together with system specific information related to humans to simulate and understand drug behavior in various target populations. This integrated approach informs decisions related to Investigational New Drugs and assists with the conduct and optimal design of clinical studies. The ultimate aim is to better understand drug PK/PD properties, reduce the cost and time of drug development, improve the quality of regulatory submissions, and eventually implement precision medicine. Read More

Population‐based Mechanistic Assessment of Drugs Pro arrhythmic Potency Using In‐vitro and In‐vivo Extrapolation Approach. The aim of the workshop is to present how mechanistic M&S can be used for the assessment of a drug’s pro-arrhythmic potency within target populations. Cardiac Safety Simulator can be used in the early stage of the drug development as a screening tool even in situations where no in-vitro data are available, or later at the clinical level to assess drug-drug or drug-physiology interactions. The case studies will cover various elements of cardiac safety assessment including in vitro ion channels inhibition, clinical surrogates of cardiac safety and role of population variability all within the framework of simulated clinical trials. Participants will learn how to choose the most suitable models and also investigate the impact of various relevant assumptions on model performance. Read More

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