First announcement: Advanced course on Pharmacometrics May 10-12 2016 The Rizzo Conference Center in Chapel Hill, NC (USA)

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 : Advanced course on Pharmacometrics May 10-12, 2016: The Rizzo Conference Center in Chapel Hill, NC (USA) 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 : The Rizzo Conference Center in Chapel Hill, North Carolina (USA): http://www.rizzoconferencecenter.com/ http://www.rizzoconferencecenter.com/ 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] Phone: +33(0) 983 24 3188 Mobile: +33(0) 760 45 1976 http://www.pharmacometrica.com/ www.pharmacometrica.com Next workshops on pharmacometrics: http://pharmacometricaworkshop.webs.com/ http://pharmacometricaworkshop.webs.com/