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Modeling & Simulation Webinar

Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
Event Overview
Proposed study designs and dosing recommendations can be evaluated and compared, using model-based simulation. By integrating available in-house and literature data in mathematical dose-exposure-response (therapeutic and adverse) models, the expected influence of various key factors on study outcome, can be explored. Non-informative study designs and sub-optimal dosing regimens may thereby be avoided, reducing cost and development times. In addition, clinical trial simulations optimize the company go/no-go decision making process and support its arguments and quantitative evidence in regulatory interactions. In this webcast, industry experts will provide the concepts around clinical trial simulation and present through case studies how modelling and simulation can expedite drugs from early to late stages of development across different therapeutic areas.

The webcast will address:
  • How can PK/PD and drug-disease models be used for making inference?
  • What is the impact of mechanistic vs empirical model, longitudinal vs fix time-point analyses, uncertainty, sub-populations, between- and within-subject variability?
  • When should the probability of a successful study outcome be simulated?
  • Why can this methodology improve internal and regulatory decision-making?
Key Learning Objectives
  • How clinical trial simulation can be used to justify study design
  • Why model-based simulations should guide dose selection
  • Why clinical trial simulation can reduce the risk of failure at Phase III
Who Should Attend
  • Head of R&D
  • Head of Biometrics
  • Clinical Pharmacology & PK/PD Modeling Managers
  • Clinical Research Managers
  • Project Managers

Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection, and Go/No-Go Inves... by Ruben Faelens on Scribd

Alberto Russu
Alberto Russu
Senior Scientist Pharmacometrics
Global Clinical Pharmacology
Janssen Research and Development
Per Olsson
Per Olsson Gisleskog
Principal Consultant
SGS Exprimo
Lisa Henderson
Lisa Henderson
Editorial Director
Applied Clinical Trials
Sponsored by:
Presented by:
Applied Clinical Trials
Have any questions? Contact Kristen Moore at
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