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 for improving the decision-making process during drug development, to help scientists to develop and use predictive models for describing complex PK profiles, establishing in-vitro/in-vivo correlation, and predicting the time course of drug effects in presence of confounding factors such as placebo effect and tolerance. Furthermore, novel methodologies are presented for optimizing drug performance using surface response analysis in combination with integrated drug-disease-trial models. Course outline Advanced PK modeling * Characterize the complex in-vivo absorption processes of 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 Advanced exposure-response modeling * Evaluate the relationship between drug exposure and clinical response * Develop models accounting for the confounding role of time varying placebo response in the assessment of the clinical response * Handling acute tolerance effect * Estimate the probability of clinical benefit of a treatment Optimizing drug performances * Implement drug optimization strategies using surface-response analysis * Determine the relationship between drug delivery and clinical benefit * Determine dose, dosage regimen and dosing strategies for optimizing the clinical benefit Course objectives * To develop population PK models for describing multiphase absorption profiles * To implement IVIVC using convolution-based modeling approach * To implement exposure-response models accounting for time varying placebo response and drug relate response * To evaluate the relative impact of the immediate and the delayed drug release on the therapeutic response * To determine the optimal drug formulation profiles for optimizing the performances of novel drug formulations * To evaluate optimal drug performances (i.e. dose, dosage regimen, in-vivo release properties) using surface response analysis and non-linear optimizer tools 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 PharmacoMetrica Longcol, 12270 La Fouillade (France) E-mail: <mailto:roberto.gom...@pharmacometrica.com> roberto.gom...@pharmacometrica.com Phone: +33(0) 983 24 3188 Mobile: +33(0) 760 45 1976 <http://www.pharmacometrica.com/> www.pharmacometrica.com
