Model-informed Drug Development Intensive Interactive Courses

Online & In-Person options available

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From Discovery to First-in-human (FIH) Using IVIVE-PBPK Modeling In this focused workshop you will use the dynamic models within the Simcyp Discovery Simulator to prioritise compounds for progress to the next stage of development using information available in early drug discovery. You will use information on clearance, absorption, tissue distribution and DDI liability to inform compound selection. Finally, from the originally large database, only a few compounds will be selected for FIH and the simulation results compared with available clinical data. The case studies will cover various elements of model development including absorption, distribution and elimination. Optimal in vitro and clinical data sets will be discussed. Participants will learn how to choose the most suitable models and also investigate the impact of various relevant assumptions on model performance. Requirements for regulatory submissions will also be discussed. It is assumed that the participants have some familiarity with the fundamentals of PBPK modeling and have hands-on experience. Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

September 30 - October 4, 2024 | ONLINE Predicting and evaluating complex DDIs—application of the Simcyp Population-based Simulator to real-life cases. Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

***This Course is only open to SIMCYP ACADEMIC RESEARCH LICENSE HOLDERS*** This PBPK boot camp is an ideal way to enhance the continuous education of students conducting research in the areas of Discovery, Drug Metabolism and Pharmacokinetics (DMPK), Clinical Pharmacology, Pharmaceutical and Drug Development and, it will provide an excellent opportunity to develop skills and remain informed of the latest scientific advances using Simcyp Simulator as the state of the art PBPK modelling platform. This 4-day workshop will comprise of lectures delivered by leading experts in the fields of PBPK modelling and will cover some of the major topics in model-informed drug development in-depth. Monday 22 July - Introduction to IVIVE linked PBPK modelling Tuesday 23 July - Incorporation of physiological variability in prediction of PK profiles Wednesday 24 July - PBPK modelling to predict drug-drug interactions (enzymes and transporters) Thursday 25 July - Office hour / Question & Answer Session Read more

This course broadens the range and utilization of in silico-based mechanistic prediction and analysis of drug absorption after oral delivery, including the development of mechanistic physiologically based in vitro-in vivo correlations (IVIVCs), virtual bioequivalence (VBE) concepts, and application of biopharmaceutic IVIVE using the SIVA Toolkit. We strongly recommend attending Oral Absorption I before taking this workshop. Read more

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