Workshop on Convolution-based modeling approach March 11-13, 2019: Fort Lauderdale, FL (USA)
This three-day, hands-on course provides a working knowledge of the theories and application of the state-of-the-art convolution-based modeling approach to characterize complex PK profiles, to establish in-vitro in-vivo correlation (IVIVC) and to optimize ER and LAI formulation development using the exposure-response relationship. The course is structured in the following sections: 1. Convolution based model * Development of convolution-based models * Modeling single and repeated doses administration using convolution-based approach in NONMEM * Development of an R based simulator for convolution-based models 2. Modeling complex absorption process * Definition and implementation in NONMEM of typical and user defined input function models, to characterize delayed, multiple peaks and time dependent absorption process * Characterize the complex in-vivo absorption processes of extended release formulations (ER) and Long Acting Injectable (LAI) formulations using convolution-based approach 3. Implementing Level A IVIVC * Definition of Level A IVIVC * Implementation of a Level A IVIVC using convolution-based models in NONMEM * The concept of time-scaling * Definition of time scaling functions for assessing IVIVC in NONMEM * Evaluate the quality of an IVIVC model and the predictive performances of an IVIVC model 4. Optimizing drug performances * Definition of drug/formulation optimization strategies using surface-response analysis, clinical trial simulation and convolution-based models * Development of an R based optimizer * Determine the relationship between drug delivery and clinical benefit using the outcome of an IVIVC analysis * Determine dose, dosage regimen and dosing strategies for optimizing the clinical benefit using the outcomes of the IVIC analysis Interactive and real life examples, taken from actual industry experience using R and NONMEM will be presented and discussed in the hands-on sections to illustrate how to deal with delayed, multiple peaks and time dependent absorption process, how to establishing a Level A IVIVC using a model-informed approach and how to develop optimized formulations with an in-vivo drug release suitable to maximize the clinical benefit of a treatment. For additional information, visit our website: <https://www.pharmacometrica.com/next-workshop> https://www.pharmacometrica.com/next-workshop Roberto Gomeni, PhD. Pharmacometrica Longcol, 12270 La Fouillade (France) E-mail: <mailto:[email protected]> [email protected] www.pharmacometrica.com <http://www.pharmacometrica.com/> Next workshops on pharmacometrics: <https://www.pharmacometrica.com/next-workshop> https://www.pharmacometrica.com/next-workshop
