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From: roberto gomeni <roberto.gomeni>
Date: Wed, 17 Jun 2015 15:54:05 +0200

Dear Colleague,


Registration is open for the:


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-tri=
al model strategy for optimizing the drug development process using convolu=
tion-based methodologies and optimal design strategies.


Course outline

• Determine the modelling strategy for characterizing the in-v=
ivo absorption processes for extended release formulations using convolutio=
n-based approach

• Evaluate In-Vitro/In-Vivo correlation methods, including con=
volution-deconvolution approach

• Evaluate the relationship between extended release drug expo=
sure and clinical response in presence of placebo effect and acute toleranc=

• Determine the relationship between drug delivery and clinica=
l response

• Determine the In-Vitro drug release to optimize the clinical=

• Determine the optimal study design methodology for study in =
a pediatric population for extended release formulations using the PopED so=


Course objectives

• To develop a population PK model for describing multiphase a=
bsorption profiles

• To evaluate alternative placebo response models

• To develop indirect-response model to jointly evaluate the p=
lacebo and drug relate response

• To evaluate the relative impact of the immediate and the del=
ayed drug release on the therapeutic response

• To use convolution-deconvolution methods for linking in-vitr=
o to in-vivo outcomes

• To determine the optimal drug formulation profiles for optim=
izing 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 re=
sponse in presence of placebo and active drug response,

⁻ the estimation of the optimal in-vitro dissolution profil=

Additional details are available at:

Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC


Longcol, 12270 La Fouillade (France)

E-mail: roberto.gomeni

Next workshops on pharmacometrics:



L'absence de virus dans ce courrier électronique a été v=
rifiée par le logiciel antivirus Avast.

Received on Wed Jun 17 2015 - 09:54:05 EDT

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