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[NMusers] Advanced course on Pharmacometrics

From: Roberto Gomeni <>
Date: Fri, 23 Jan 2015 13:42:20 +0100

Dear Members,


Don’t miss this exciting opportunity to learn novel pharmacometrics
approaches for improving the efficiency of clinical trials.


Pharmacometrica will be holding an advanced course on pharmacometrics at th=
Chateau de Longcol (France):

Advanced course on Pharmacometrics

30 March - 2 April 2015

Château de Longcol, Longcol, La Fouillade (France


Course outline

Develop and implement a pharmacometric and optimal study design strategies:=

a) To evaluate the relationship between the exposure of an active drugs
(methylphenidate-MPH) and the clinical response in presence of placebo
effect for the treatment of the Attention Deficit/Hyperactivity Disorder
(ADHD) disease in children,

b) To determine the relationship between the drug delivery and the
clinical response,

c) To determine the optimal study design in a pediatric population for
evaluating new formulations of MPH.


MPH is a CNS stimulant that is thought to block the reuptake of dopamine an=
noradrenaline (norepinephrine) into the presynaptic neuron. A sustained
release (OROS formulation) of the drug has been developed for use in
children with ADHD. The OROS delivery technology provides a mixture of
immediate and delayed release. Within 1 hour, plasma MPH concentrations
reach an initial plateau, followed by a gradual increase over the next 5 to=

9 hours. The behavioral manifestations of ADHD during analog classroom
sessions following placebo of MPH treatment will be determined using the
longitudinal changes in the SKAMP Rating Scale.


Course objectives

· To develop a population PK model for describing the complex absorpti=
profile of an OROS formulation of MPH

· To develop a placebo response model in children with ADHD

· To develop an indirect-response model to jointly evaluate the placeb=
and drug relate response

· To evaluate the relative impact of the immediate and the delayed
release of MPH (administered using the OROS formulation) on the
therapeutic response

· To determine the optimal study design in pediatric population for
assessing the performances of novel formulations of MPH.


Topics include

· Methods for digitalizing images and for generate working data (PK,
placebo, PD) by extracting data from selected publications

· Placebo response and drug action model development

· Indirect model PKPD model development for jointly analyze placebo an=
MPH related response

· Evaluation of alternative models for describing complex absorption P=

· Evaluation of alternative models for describing the placebo and the =

· Implementation of an R based simulator for generating virtual data
describing the population PK and clinical responses (placebo and drug

· Optimization of the study design in pediatric population using optim=
design methods

· Implementation of the overall pharmacometrics projects using a
pipelining workflow solution using a visual graphical GUI and R as task
definition language.


Additional details are available at:




Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC


Longcol, 12270 La Fouillade (France)

E-mail: <>


Next workshops on pharmacometrics:


L'absence de virus dans ce courrier électronique a été vérifiée p=
ar le logiciel antivirus Avast.

Received on Fri Jan 23 2015 - 07:42:20 EST

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