Simcyp Workshop - PAGE Satellite Meeting

Venue: Divani Caravel Hotel

Location: Athens, Greece

Event Date/Time: Jun 07, 2011 End Date/Time: Jun 07, 2011
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The course focuses on the contrasts between ‘classical POP-PK analysis of clinical data’ and ‘bottom-up PBPK/PD approaches combined with population data analysis’. This bridging helps with covariate recognition, model building and rational design of studies.

The examples include fitting minimal and full PBPK-derived concentration-time profiles, mechanistic absorption models with transit compartments, drug-drug interaction and various direct and indirect response models. Attendees will learn about individual parameter fitting and the application of classical approaches such as Nelder-Mead and Hooke-Jeeves in minimising Weighted Least Square objective functions. 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 is used to estimate the population and individual’s parameters.

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.