ADVANCED COURSE ON PHARMACOMETRICS
Dear Colleague,
Registration is open for the:
ADVANCED COURSE ON PHARMACOMETRICS
16 November to 18 November 2015
Château de Longcol, Longcol, La Fouillade (France)
This is a 4-day course designed to develop and implement a drug-disease-trial
model strategy for optimizing the drug development process using
convolution-based methodologies and optimal design strategies.
Course outline
• Determine the modelling strategy for characterizing the in-vivo
absorption processes for extended release formulations using convolution-based
approach
• Evaluate In-Vitro/In-Vivo correlation methods, including
convolution-deconvolution approach
• Evaluate the relationship between extended release drug exposure and
clinical response in presence of placebo effect and acute tolerance
• Determine the relationship between drug delivery and clinical response
• Determine the In-Vitro drug release to optimize the clinical response
• 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
• To present and use in the hands-on session the Shiny R based package for
implementing:
⁻ the convolution/deconvolution analysis,
⁻ a 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
Additional details are available at: www.pharmacometricaworkshop.webs.com
Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC
PharmacoMetrica
Longcol, 12270 La Fouillade (France)
E-mail: [email protected]
www.pharmacometrica.com
Next workshops on pharmacometrics: http://pharmacometricaworkshop.webs.com
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antivirus Avast.
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