Advanced course on Pharmacometrics

Dear All, Pharmacometrica will be holding an advanced course on pharmacometrics at the Chateau de Longcol (France): Advanced course on Pharmacometrics 30 March - 2 April 2015 Château de Longcol, Longcol, La Fouillade (France) Course outline Develop and implement a pharmacometric and optimal study design strategies: a) To evaluate the relationship between the exposure of an active drugs (methylphenidate-MPH) and the clinical response in presence of placebo effect for the treatment of the Attention Deficit/Hyperactivity Disorder (ADHD) disease in children, b) To determine the relationship between the drug delivery and the clinical response, c) To determine the optimal study design in a pediatric population for evaluating new formulations of MPH. MPH is a CNS stimulant that is thought to block the reuptake of dopamine and noradrenaline (norepinephrine) into the presynaptic neuron. A sustained release (OROS formulation) of the drug has been developed for use in children with ADHD. The OROS delivery technology provides a mixture of immediate and delayed release. Within 1 hour, plasma MPH concentrations reach an initial plateau, followed by a gradual increase over the next 5 to 9 hours. The behavioral manifestations of ADHD during analog classroom sessions following placebo of MPH treatment will be determined using the longitudinal changes in the SKAMP Rating Scale. Course objectives · To develop a population PK model for describing the complex absorption profile of an OROS formulation of MPH · To develop a placebo response model in children with ADHD · To develop an indirect-response model to jointly evaluate the placebo and drug relate response · To evaluate the relative impact of the immediate and the delayed release of MPH (administered using the OROS formulation) on the therapeutic response · To determine the optimal study design in pediatric population for assessing the performances of novel formulations of MPH. Topics include · Methods for digitalizing images and for generate working data (PK, placebo, PD) by extracting data from selected publications · Placebo response and drug action model development · Indirect model PKPD model development for jointly analyze placebo and MPH related response · Evaluation of alternative models for describing complex absorption PK profiles · Evaluation of alternative models for describing the placebo and the MPH response · Implementation of an R based simulator for generating virtual data describing the population PK and clinical responses (placebo and drug related) · Optimization of the study design in pediatric population using optimal design methods · Implementation of the overall pharmacometrics projects using a pipelining workflow solution using a visual graphical GUI and R as task definition language. 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/ --- L'absence de virus dans ce courrier électronique a été vérifiée par le logiciel antivirus Avast. http://www.avast.com