There are still some places available on the upcoming Pharmacometrics Workshop on Convolution-based modeling approach
There are still some places available on the upcoming Pharmacometrics
Workshop on Convolution-based modeling approach. March 11-13, 2019: Fort
Lauderdale, FL (USA)
This three-day, hands-on course provides a working knowledge of the theories
and application of the state-of-the-art convolution-based modeling approach
to characterize complex PK profiles, to establish in-vitro in-vivo
correlation (IVIVC) and to optimize ER and LAI formulation development using
the exposure-response relationship.
The course is structured in the following sections:
1. Convolution based model
* Development of convolution-based models
* Modeling single and repeated doses administration using
convolution-based approach in NONMEM
* Development of an R based simulator for convolution-based models
2. Modeling complex absorption process
* Definition and implementation in NONMEM of user defined input
functions to characterize delayed, multiple peaks and time dependent
absorption process
* Characterize the complex in-vivo absorption processes of extended
release formulations (ER) and Long Acting Injectable (LAI) formulations
using convolution-based approach
3. Implementing Level A IVIVC
* Definition of Level A IVIVC
* Implementation of a Level A IVIVC using convolution-based models in
NONMEM
* The concept of time-scaling
* Definition of time scaling functions for assessing IVIVC in NONMEM
* Evaluate the quality of an IVIVC model and the predictive
performances of an IVIVC model
4. Optimizing drug performances
* Definition of drug/formulation optimization strategies using
surface-response analysis, clinical trial simulation and convolution-based
models
* Development of an R based optimizer
* Determine the relationship between drug delivery and clinical
benefit using the outcome of an IVIVC analysis
* Determine dose, dosage regimen and dosing strategies for
optimizing the clinical benefit using the outcomes of the IVIVC analysis
Interactive and real life examples, taken from actual industry experience
using R and NONMEM will be presented and discussed in the hands-on sections
to illustrate how to deal with delayed, multiple peaks and time dependent
absorption process, how to establishing a Level A IVIVC using a
model-informed approach and how to develop optimized formulations with an
in-vivo drug release suitable to maximize the clinical benefit of a
treatment.
Supportive material can be found in our recent paper published in the CPT
Pharmacometrics Syst Pharmacol. journal:
https://www.ncbi.nlm.nih.gov/pubmed/30659771
For additional information, visit our website:
https://www.pharmacometrica.com/next-workshop
https://www.pharmacometrica.com/next-workshop
Roberto Gomeni, PhD.
Pharmacometrica
Longcol, 12270 La Fouillade (France)
E-mail: <mailto:roberto.gomeni_at_pharmacometrica.com>
roberto.gomeni_at_pharmacometrica.com
www.pharmacometrica.com http://www.pharmacometrica.com/