Register NOW Advanced Course on Applied Pharmacometrics
November 14-16, 2016: Château de Longcol, Lieu-dit 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 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 at UNC Pharmacometrica Longcol, 12270 La Fouillade (France) E-mail: <mailto:roberto.gom...@pharmacometrica.com> roberto.gom...@pharmacometrica.com <http://www.pharmacometrica.com/> www.pharmacometrica.com Next workshops on pharmacometrics: http://pharmacometricaworkshop.webs.com/
