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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)
Jade Huguet, PHD
Associate Director Clinical Pharmacology Clinical Pharmacology/Translational Med, Certara, Canada
Dose Optimization for Rare Cancers
Utkarsh Dang, PHD
Associate Professor, Carleton University, Canada
Statistical Considerations for Trial Design in Rare Diseases: Examples from Duchenne and Becker Muscular Dystrophy
Alex Bliu, PHD
Senior Biostatistician, Health Canada, Canada
Statistical Regulatory Challenges for the Design of Studies with Small Populations
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