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Simcyp workshop at PAGE meeting
Model Fitting and PD Related Trial Design Using Simcyp
“Fitting Observed Data using Pre-Compiled PBPK Models (small and large molecules) and Trial Simulation of PD Outcome”
Simcyp is running a one-day hands-on workshop on Tuesday 11th June, giving an opportunity for attendees to familiarise themselves with this increasingly popular platform. The software is being used by many groups for the purpose of simulations and in vitro-in vivo extrapolation as part of their regulatory packages. However, pharmacometric features, such as user-defined PD models and powerful fitting tools for complex PBPK models, are less commonly known outside of DMPK circles. These capabilities are available for both small and larger molecules. The course will bridge mechanistic covariate recognition, complex model fitting and rational design of studies.
The examples include fitting minimal and full PBPK-derived concentration-time profiles, mechanistic FcRn model without/with Target Mediated Drug Disposition (TMDD) models, pre-defined and user-defined response models. Attendees will learn how to code their pharmacodynamics models using Lua programming language. Individual parameter fitting and the application of classical approaches such as Nelder-Mead and Hooke-Jeeves in minimising weighted least square (WLS) objective functions will be explained. More modern hybrid methods, such as genetic algorithms, will be discussed and demonstrated. For population fitting, maximum likelihood (ML) algorithm using the Monte Carlo expectation maximisation (MCEM) approach will be used to estimate parameters in populations and in individuals.
Only a rudimentary knowledge of PBPK is assumed and the concepts and practical applications of integrating available in vitro data and physiological knowledge with clinical observations for estimating unknown/uncertain drug or physiological parameters will be reviewed.
Academics & Simcyp Consortium Member Companies £75 / Non Members £200.
The registration fee includes course materials, access to laptop computers, refreshments & lunch.
Online booking for Simcyp events is handled through the Simcyp Members’ Area. Your saved profile is automatically captured on the booking form so there is no need to re-enter your contact details. Click here to link to the booking form – you will be prompted for your Simcyp Members’ Area user name (email address) and password. If you have forgotten your log-in credentials please follow the instructions on-screen. If you do not currently have an account, please follow the link to register.