9th Advanced course on Pharmacometrics

PharmacoMetrica is holding the: 9th Advanced course on Pharmacometrics October 9-11, 2017: Chateau de Longcol (France) This is a 3-day course designed to present advanced concepts on pharmacometrics using novel methodologies based on integrated drug-disease-trial models and surface response analysis. Case studies are presented to illustrate how these tools can be used for improving the decision-making process during drug development, for facilitating the development and use of predictive models for describing complex PK profiles, in-vitro/in-vivo correlation, and exposure-response relationships in presence of confounding factors such as placebo effect and tolerance. Course objectives To present concepts and practical solutions for: Advanced PK modeling * To characterize the complex in-vivo absorption processes of extended release formulations (ER) and Long Acting Injectable (LAI) formulations using convolution-based approach * To evaluate In-Vitro/In-Vivo correlation methods, including convolution-deconvolution approach Advanced exposure-response modeling * To evaluate the relationship between drug exposure and clinical response * To develop models accounting for the confounding role of time varying placebo response in the assessment of the clinical response * To develop integrated disease-drug-trial models * To handle acute tolerance effect * To estimate the probability of clinical benefit of a treatment Optimizing drug performances * To implement drug optimization strategies using surface-response analysis * To determine the relationship between drug delivery and clinical benefit * To determine dose, dosage regimen and dosing strategies for optimizing the clinical benefit Course material The R scripts (including Shiny based applications) used in the hands-on sessions and the NONMEM control streams will be distributed to the participants. The material includes: o the convolution/deconvolution analysis, o the clinical trial simulator for describing the clinical response in presence of placebo and active drug response, o the estimation of the optimal in-vitro dissolution profiles o the convolution/deconvolution analysis, o the non-linear optimizer used in the surface-response analysis Venue: Chateau de Longcol (France): http://www.chateadelongcol.com/ http://www.chateadelongcol.com/ Additional details are available at: http://pharmacometricaworkshop.webs.com/ http://pharmacometricaworkshop.webs.com/ Roberto Gomeni, PhD, HDR, Adjunct Professor with the Division of Pharmacotherapy and Experimental Therapeutics in the UNC Eshelman School of Pharmacy at The University of North Carolina at Chapel Hill Pharmacometrica Longcol, 12270 La Fouillade (France) E-mail: <mailto:[email protected]> [email protected] http://www.pharmacometrica.com/ www.pharmacometrica.com