Model-informed Drug Development Intensive Interactive Courses

Limited Availability on all Courses for 2021

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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.   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

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

Predicting pharmacokinetics and pharmacodynamics of therapeutic proteins and antibody drug conjugates, and bispecific antibodies. This workshop will introduce the mechanistic PBPK models available for therapeutic proteins, antibody drug conjugates and bispecific antibodies with participants learning how to apply these models. 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

In this focused workshop participants will use the dynamic models within the Simcyp Simulator to prioritize compounds for progress to the next stage of development using information available in early drug discovery. Participants 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 DDIs, special populations to pre-clinical species, transporters, and different formulations. Optimal in vitro and clinical data sets for PBPK model building 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. An appraisal of regulatory requirement for FIH studies and considerations for regulatory acceptance of PBPK simulations will be discussed. It is assumed that the participants are familiar 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

Broadening the range and utilization of in silico-based mechanistic prediction and analysis of drug absorption after non-oral application. Mechanistic modeling of the topical drug application, development of mechanistic physiologically-based in vitro-in vivo correlations (IVIVCs), and virtual bioequivalence (VBE) concepts. 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

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. 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

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