Advanced course on Pharmacometrics

Dear Members, Don’t miss this exciting opportunity to learn novel pharmacometrics approaches for improving the efficiency of clinical trials. 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