modeling and simulation in drug development with simbiology®
TRANSCRIPT
11
Modeling Approaches in Drug Development
Discovery Preclinical studies Clinical studies
▪ Assess safety and efficacy
▪ Define target population (popPK/vPop)
▪ Identify drug target ▪ Does the drug reach the target?
▪ Find safe and efficient dose for
first in-human study
Systems Biology (PB)PK / PD
Quantitative Systems Pharmacology (QSP)
22
What is SimBiology?
Build a model
by drawing itSimulate a model Estimate parameters Analyze a model
SimBiology® provides Apps and programmatic tools to:
33
SimBiology and the MATLAB ecosystem
SimBiology
SimBiology
project
• Programming language
• Rigorously tested, maintained and updated
• App-based and programmatic workflows
• Comprehensive set of built-in analysis tools
• Accelerate simulations by compiling to C-code
• Projects promote continuity and reproducibility of results
• Graphical model representation
MATLAB
4
Examples of published user projects
66
Share your simulation App via an URL in your intranet
Use App Designer to
create MATLAB apps
Use App Designer to
create MATLAB Apps
Author
Use MATLAB Compiler
to package
Package
Domain Expert
Host
Use MATLAB Web App
Server to deploy and
share
IT System Administrator
88
SimBiology Community: an online community for users
An online gathering place
▪ for scientists in QSP, PBPK,
PK/PD modeling
▪ to discuss, share code and
models, projects and more
▪ to facilitate growth of modeling
and SimBiology communities
Leading SimBiology users are part of
this community
99
Learn More
SimBiology Tutorials for QSP, PBPK, and PK/PD Modeling and Analysis : Video Series
▪ Physiologically-based Modeling of Oral Drug Absorption with SimBiology
▪ Integrating PK/PD and Mechanistic Modeling with SimBiology and MATLAB
▪ Compliance with FDA/CE Regulations and Standards