Dear NMusers,
This is the second announcement for the: Advanced course on Pharmacometrics 16 - 18 Nov. 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 using the NONMEM software * 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 appropriate for optimizing the clinical response * <http://www.pharmacometrica.com/> Determine the optimal study design methodology for study in a pediatric population for extended release formulations using the PopED software Course objectives * To develop population PK models 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 an R based package for implementing: a. the convolution/deconvolution analysis, b. a clinical trial simulator for describing the clinical response in presence of placebo and active drug response, c. the estimation of the optimal in-vitro dissolution profiles Additional details are available at: <http://pharmacometricaworkshop.webs.com/> http://pharmacometricaworkshop.webs.com/ Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC Pharmacometrica Longcol, 12270 La Fouillade (France) E-mail: <mailto:[email protected]> [email protected] <http://www.pharmacometrica.com/> www.pharmacometrica.com Next workshops on pharmacometrics: <http://pharmacometricaworkshop.webs.com/> http://pharmacometricaworkshop.webs.com/
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