NONMEM Users Network Archive

Hosted by Cognigen

[NMusers] 9th Advanced course on Pharmacometrics

From: roberto gomeni <roberto.gomeni_at_pharmacometrica.com>
Date: Mon, 15 May 2017 16:20:46 +0200

PharmacoMetrica is holding the:

 

9th Advanced course on Pharmacometrics

October 9-11, 2017: Chateau de Longcol (France)

 

This is a 3-day course designed to present advanced concepts on
pharmacometrics for improving the decision-making process during drug
development, to help scientists to develop and use predictive models for
describing complex PK profiles, establishing in-vitro/in-vivo correlation,
and predicting the time course of drug effects in presence of confounding
factors such as placebo effect and tolerance. Furthermore, novel
methodologies are presented for optimizing drug performance using surface
response analysis in combination with integrated drug-disease-trial models.

 

 

Course outline

 

Advanced PK modeling

* Characterize the complex in-vivo absorption processes of 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

 

Advanced exposure-response modeling

* Evaluate the relationship between drug exposure and clinical
response

* Develop models accounting for the confounding role of time varying
placebo response in the assessment of the clinical response

* Handling acute tolerance effect

* Estimate the probability of clinical benefit of a treatment

 

Optimizing drug performances

* Implement drug optimization strategies using surface-response
analysis

* Determine the relationship between drug delivery and clinical
benefit

* Determine dose, dosage regimen and dosing strategies for
optimizing the clinical benefit

 

Course objectives

 

* To develop population PK models for describing multiphase
absorption profiles

* To implement IVIVC using convolution-based modeling approach

* To implement exposure-response models accounting for time varying
placebo response and drug relate response

* To evaluate the relative impact of the immediate and the delayed
drug release on the therapeutic response

* To determine the optimal drug formulation profiles for optimizing
the performances of novel drug formulations

* To evaluate optimal drug performances (i.e. dose, dosage regimen,
in-vivo release properties) using surface response analysis and non-linear
optimizer tools

 

Course material

 

The R scripts (including Shiny based applications) used in the hands-on
sessions and the NONMEM control streams will be distributed to the
participants. The material includes:

 

o the convolution/deconvolution analysis,

o the clinical trial simulator for describing the clinical response in
presence of placebo and active drug response,

o the estimation of the optimal in-vitro dissolution profiles

o the convolution/deconvolution analysis,

o the non-linear optimizer used in the surface-response analysis

 

.

 

Venue: Chateau de Longcol (France): <http://www.chateadelongcol.com/>
http://www.chateadelongcol.com/

 

Additional details are available at:
<http://pharmacometricaworkshop.webs.com/>
http://pharmacometricaworkshop.webs.com/

 

 

 

Roberto Gomeni, PhD, HDR

PharmacoMetrica

Longcol, 12270 La Fouillade (France)

E-mail: <mailto:roberto.gomeni_at_pharmacometrica.com>
roberto.gomeni_at_pharmacometrica.com

Phone: +33(0) 983 24 3188

Mobile: +33(0) 760 45 1976

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

 

 




Received on Mon May 15 2017 - 10:20:46 EDT

The NONMEM Users Network is maintained by ICON plc. Requests to subscribe to the network should be sent to: nmusers-request@iconplc.com. Once subscribed, you may contribute to the discussion by emailing: nmusers@globomaxnm.com.