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Session 8, Track B: Statistical, Modeling and Dose Optimization Considerations for Trial Design
Session Chair(s)
Oxana Iliach, PhD
Senior Director Regulatory Strategy
Certara, Canada
Katalin Bertenyi, MSc
Manager, Centre for Blood, Blood Products and Biotherapeutics
Health Canada, Canada
This session will provide an overview of current approaches to optimization of doses with focus on oncology studies, statistical consideration for the studies with the small population and latest updates in this area from Health Canada.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe project Optimus objectives and current status
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Discuss statistical considerations for the design of the study with the small population
- Explain latest Health Canada advancement and requirements for the statistical approaches in the clinical studies
Speaker(s)
FDA’s Project Optimus: An Overview
Jade Huguet, PhD
Certara, Canada
Associate Director Clinical Pharmacology Clinical Pharmacology/Translational Med
Statistical Considerations for Trial Design in Rare Diseases: Examples from Duchenne and Becker Muscular Dystrophy
Utkarsh Dang, PhD
Carleton University, Canada
Associate Professor
Statistical Regulatory Challenges: Health Canada Perspective
Alex Bliu, PhD
Health Canada, Canada
Senior Biostatistician
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