Advanced course on Pharmacometrics May 10-12 2016 The Rizzo Conference Center in Chapel Hill, NC�(USA)

Dear Members, Second announcement. Don’t miss this exciting opportunity to learn novel pharmacometrics approaches for improving the efficiency of clinical trials. Pharmacometrica will be holding an advanced course on pharmacometrics : Advanced course on Pharmacometrics May 10-12, 2016: The Rizzo Conference Center in Chapel Hill, NC (USA) Course outline * Determine the modelling strategy for characterizing the complex in-vivo absorption processes for extended release formulations (ER) and Long Acting Injectable (LAI) formulations using convolution-based approach * Evaluate In-Vitro/In-Vivo correlation methods, including convolution-deconvolution approach * Evaluate the relationship between drug exposure of extended release formulations and clinical response in presence of placebo effect and acute tolerance * Determine the relationship between drug delivery and clinical benefit * Determine the In-Vitro drug release to optimize the clinical benefit * Illustrate how the convolution-based approach can be used to optimize the performances of ER and LAI formulations * Determine the optimal study design methodology for study in a pediatric population for extended release formulations using the PopED software Course objectives * To develop a population PK model for describing multiphase absorption profiles * To evaluate alternative placebo response models * To develop indirect-response model to jointly evaluate the placebo and drug relate response * To evaluate the relative impact of the immediate and the delayed drug release on the therapeutic response * To use convolution-deconvolution methods for linking in-vitro to in-vivo outcomes * To determine the optimal drug formulation profiles for optimizing the performances of novel drug formulations * To evaluate optimal study design methodologies Course material * The R scripts (including Shiny based applications) used in the hands-on sessions and the NONMEM control streams used for implementing: * the convolution/deconvolution analysis, * the clinical trial simulator for describing the clinical response in presence of placebo and active drug response, * the estimation of the optimal in-vitro dissolution profiles * the convolution/deconvolution analysis, will be distributed to the participants. Venue : The Rizzo Conference Center in Chapel Hill, North Carolina (USA): http://www.rizzoconferencecenter.com/ http://www.rizzoconferencecenter.com/ Pre-view and play with our Shiny-based simulator by running on your PC or mobile device a PK/PD case study: http://www.pharmacometricasimulation.webs.com www.pharmacometricasimulation.webs.com Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC Pharmacometrica Longcol, 12270 La Fouillade (France) E-mail: <mailto:roberto.gomeni_at_pharmacometrica.com> roberto.gomeni_at_pharmacometrica.com Phone: +33(0) 983 24 3188 Mobile: +33(0) 760 45 1976 http://www.pharmacometrica.com/ www.pharmacometrica.com Next workshops on pharmacometrics: http://pharmacometricaworkshop.webs.com/ http://pharmacometricaworkshop.webs.com/