Clinical Trial Simulation; an Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions

Sep 19, 2017

Register Free: http://www.appliedclinicaltrialsonline.com/act_w/simulation

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? 

 

Speakers:

Alberto Russu, Senior Scientist Pharmacometrics, Global Clinical Pharmacology, Janssen Research and Development

Per Olsson Gisleskog, Principal Consultant, SGS Exprimo

 

Date and Time:

Europe: Tuesday, 19 September 2017 | 1400 BST | 1500 CEST

North America: Thursday, 28 September 2017 | 10 am EDT | 9 am CDT

After the final airing of the webcast 19 September 2017 it will be available on demand until 19 September 2018. 

Register Free: http://www.appliedclinicaltrialsonline.com/act_w/simulation

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