Workshop on Convolution-based modeling approach March 11-13, 2019: Fort Lauderdale, FL (USA)

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 IVIVC 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. Who Should Attend? The workshop is designed for pharmaceutical scientists, pharmacologists, physicians and other scientists involved in drug development wishing to learn and apply pharmacometrics as innovative decision supporting tool for accelerating drug discovery and development. What Will You Learn? Upon completion of this course, you should have a solid understanding of how to implement convolution-based models using NONMEM, how to implement IVIVC using NONMEM, how to simulate drug exposure as a function of the modified in-vivo delayed and time dependent drug release properties of ER and LAI formulations using R, and how to optimize the properties of ER and LAI formulations for maximizing the clinical benefit of a treatment. Venue Fort Lauderdale Marriott Harbor Beach Resort & Spa, 3030 Holiday Drive, Fort Lauderdale, FL 33316 USA https://www.marriott.com/hotels/travel/fllsb-fort-lauderdale-marriott-harbo r-beach-resort-and-spa/ https://www.marriott.com/hotels/travel/fllsb-fort-lauderdale-marriott-harbor -beach-resort-and-spa/ 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