Model-informed Drug Development Intensive Interactive Courses

Limited Availability on all Courses for 2021

More info

The ABC of modelling drug transporter data: Mechanistic approaches to predict the impact of drug transport proteins on ADME, Pharmacokinetics, and Toxicity Overview: This course provides a dynamic mixture of lectures, demonstrations and hands-on exercises providing a wide-array of theory and practical know how. Live demonstrations of the simulation platforms essential for consideration in developing PBPK models with transporters are given, which will facilitate the attendees learning, driven through hands-on sessions to be attempted remotely. The hands-on sessions will be re-visited the following day with the tutors providing guidance, troubleshooting tips and facilitating interactive Q&A on the exercises. 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 workshop will provide an in depth overview of generation of populations for mechanistic PBPK, focusing on key covariates to inform prediction of pharmacokinetics in healthy as well as disease populations. Key aspects of the course: – Building populations and Correlated Monte Carlo Sampling – Age matching clinical trial design – Bridging Studies - Japanese and Chinese Populations – Time varying population parameters - Pregnancy – Mechanistically accounting for impact of Disease – Renal Impairment, Cirrhosis populations – Oncology populations 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

It is assumed that the participants are familiar with the fundamentals of PBPK modeling and have hands-on experience. The main aim of this focused workshop is to demonstrate the application of best practices in developing PBPK models, and to indicate how to qualify and refine model performance. Various case studies, including some real-life examples, will be presented. The case studies will cover various elements of model development including DDIs, special populations, transporters, and different formulations. 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 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

Mechanistic oral absorption modelling and prediction of bioavailability for drug products incorporating inter-subject variability. Theory and applications of the Simcyp Advanced Dissolution, Absorption, and Metabolism (ADAM) Model. Gut wall permeability and first-pass metabolism Drug solubility, dissolution, precipitation and supersaturation Oral drug absorption incorporating food effects Bioavailability and the impact of physiology and dosage form including salts Entero-hepatic recirculation Inter-individual variability assessment Application of the SIVA Toolkit to the modeling of in vitro experiments to confirm and/or estimate parameters for PBPK simulations with a case study; mechanistic modeling of dissolution and precipitation in USP 2, USP 4, serial dilution, transfer and biphasic systems. 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

Parameter Estimation and Pharmacodynamics (PE/PD) A systems pharmacology approach to modeling and simulation—accelerating model building and covariate recognition in drug development by combining top-down and bottom-up PBPK modeling of pharmacokinetics linked to drug response. The workshop covers the concepts and the practical applications of integrating in vitro data and physiological knowledge with clinical observations for the purpose of estimating unknown/uncertain model parameters. Delegates will work through different parameter estimation examples using fitting tools and explore various PD 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

Predicting age related changes to pharmacokinetics (PK) and drug-drug interactions including associated variability—linking this information to drug response in the pediatric population. Participants will learn how PK behavior can be modeled in preterm and term neonates, infants, and children and how it can be linked to predict the drug response (PD) within the PBPK platform. Hands-on exercises explore how this valuable information is relevant to early and informed decisions to assist in the improved design of pediatric clinical studies. 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

Shopping Cart

Your cart is empty