Registration is now open for the: Advanced course on Pharmacometrics
November 14-16, 2016: Château de Longcol, La Fouillade (France). 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 and mrgsolve 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 : Château de Longcol, Lieu-dit Longcol, La Fouillade (France). <http://www.chateaudelongcol.com/> http://www.chateaudelongcol.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 with the Division of Pharmacotherapy and Experimental Therapeutics in the UNC Eshelman School of Pharmacy at The University of North Carolina at Chapel Hill PharmacoMetrica Longcol, 12270 La Fouillade (France) E-mail: <mailto:roberto.gom...@pharmacometrica.com> roberto.gom...@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/ 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
