[NMusers] Advanced course on Pharmacometrics

From: Roberto Gomeni <roberto.gomeni_at_pharmacometrica.com>
Date: Thu, 15 Jan 2015 08:54:17 +0100

Dear All,

 

Pharmacometrica will be holding an advanced course on pharmacometrics at th=
e
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=
d
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=
on
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=
o
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=
d
MPH related response

· Evaluation of alternative models for describing complex absorption P=
K
profiles

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

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

· Optimization of the study design in pediatric population using optim=
al
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:
<http://pharmacometricaworkshop.webs.com/>
http://pharmacometricaworkshop.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

 <http://www.pharmacometrica.com/> www.pharmacometrica.com

Next workshops on pharmacometrics:
<http://pharmacometricaworkshop.webs.com/>
http://pharmacometricaworkshop.webs.com/

 



---
L'absence de virus dans ce courrier électronique a été vérifiée p=
ar le logiciel antivirus Avast.
http://www.avast.com


Received on Thu Jan 15 2015 - 02:54:17 EST

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