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Satellite Workshops: PMX Analysis with R, NsLME, and Pirana Darwin

Keith Nieforth, PharmD & Mark Sale, MD

This is a full day workshop on June 25 that will introduce the student to PMX analyses in R using Certara’s R speaks NLME, Pirana, and Pirana Darwin. By the end of the course, students will be able to create a pk model in R using the PML language, fit the model, perform diagnostics including VPC, and perform simulations. In addition, students will be given an introduction to executing a machine learning model selection analysis using Pirana Darwin.

The workshop will include lectures and hands-on exercises. Participants will be given access to a cloud environment to perform the hands-on exercises.

A Hands-On Workshop with Simcyp Designer for Tailored PBPK-PD/QSP Models

Would you like to modify and tailor population PBPK models? This course will review the principles of PBPK modelling, using the Simcyp Simulator and how to use Simcyp Designer to modify existing PBPK models with your own extension and link them to custom-built PD/QSP models. We will have lectures to introduce the PBPK models to be changed and have hands-on exercises to train the customisation of PBPK models with the Designer. No prior knowledge is required. Access to the Simcyp Simulator and Simcyp Designer will be provided. Participant are required to bring their own laptops as the workshop is hands-on intensive.

Key aspects of the course:

  • Overview of PBPK modelling, using the Simcyp Simulator.
  • Rapidly create new models in a graphical editor – the Simcyp Designer.
  • Replace PBPK model components in Simcyp with a user-defined model.
  • Adding components/modules to simcyp PBPK models.
  • Extending PBPK models for large molecules.
  • Building PBPK driven PD/QSP models.
  • Incorporate population variability into the customized models.

COST £200+VAT Students (Coupon Code: STUDENT24) / £400+VAT Industry

A Hands-On Workshop on incorporating physiological covariates in Population based PK Predictions

Population pharmacokinetic analyses of covariates sometimes suffer from the “tobacco smoking syndrome” of early epidemiology, where known effects of smoking are not considered. Hunting for influencing covariates via standard analyses of epidemiological data either each time rediscover these effects or lose power.

In contrast, modern bottom-up Physiologically Based Pharmacokinetic (PBPK) approaches rely on prior knowledge and include known covariate effects in population-based PK predictions. This workshop introduces principles for incorporating covariates in the prediction of drug clearance and volume of distribution, and applies them to predict PK in various healthy and disease populations using PBPK.

The workshop covers the following key aspects:

  • Clinical examples of Physiological covariates affecting PK
  • How to incorporate physiological and genetic covariates within PBPK models
  • Quantifications of the impact of static and time-dependent covariates on clearance and volume of distribution predictions for healthy and disease populations
  • Covariates impacts on dose selection and study design

COST £200+VAT Students (Coupon Code: STUDENT24a) / £400+VAT Industry

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