ADVANCED COURSE ON PHARMACOMETRICS

From: Roberto Gomeni Date: June 17, 2015 event Source: mail-archive.com
Dear Colleague, Registration is open for the: ADVANCED COURSE ON PHARMACOMETRICS 16 November to 18 November 2015 Château de Longcol, Longcol, La Fouillade (France) This is a 4-day course designed to develop and implement a drug-disease-trial model strategy for optimizing the drug development process using convolution-based methodologies and optimal design strategies. Course outline • Determine the modelling strategy for characterizing the in-vivo absorption processes for extended release formulations using convolution-based approach • Evaluate In-Vitro/In-Vivo correlation methods, including convolution-deconvolution approach • Evaluate the relationship between extended release drug exposure and clinical response in presence of placebo effect and acute tolerance • Determine the relationship between drug delivery and clinical response • Determine the In-Vitro drug release to optimize the clinical response • 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 • To present and use in the hands-on session the Shiny R based package for implementing: ⁻ the convolution/deconvolution analysis, ⁻ a 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 Additional details are available at: www.pharmacometricaworkshop.webs.com Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC PharmacoMetrica Longcol, 12270 La Fouillade (France) E-mail: [email protected] www.pharmacometrica.com Next workshops on pharmacometrics: http://pharmacometricaworkshop.webs.com --- L'absence de virus dans ce courrier électronique a été vérifiée par le logiciel antivirus Avast. https://www.avast.com/antivirus