NONMEM Users Network Archive

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Advanced course on Pharmacometrics May 10-12 2016 Chapel Hill, NC (USA)

From: roberto gomeni <roberto.gomeni>
Date: Thu, 11 Feb 2016 17:13:34 +0100

Dear Members,


We are now open for registrations!


Please register now to the:


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

* Determine the In-Vitro drug release to optimize the clinical

* 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


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):


Pre-view and play with our Shiny-based simulator by running on your PC or
mobile device a PK/PD case study:



Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC


Longcol, 12270 La Fouillade (France)

E-mail: <mailto:roberto.gomeni

Phone: +33(0) 983 24 3188

Mobile: +33(0) 760 45 1976


Next workshops on pharmacometrics:



Received on Thu Feb 11 2016 - 11:13:34 EST

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