Few places still available
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/
Pre-view and play with our Shiny-based simulator by running on your PC or
mobile device a PK/PD case study:
http://www.pharmacometricasimulation.webs.com
www.pharmacometricasimulation.webs.com
Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC
Pharmacometrica
Longcol, 12270 La Fouillade (France)
E-mail: <mailto:roberto.gomeni_at_pharmacometrica.com>
roberto.gomeni_at_pharmacometrica.com
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/