The Clinical Utility Index, a Method for Balancing Efficacy and Safety ...

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Model-Based Approach for Competitive Product Positioning Sponsor‘s Pre-Clinical/ Clinical Data Subject-level observations (animal, patient) Modeling of New Treatment Clinical Utility Index (CUI) Metric to assess risk-benefit tradeoffs between treatment and competition Integrated Model-Based Predictions (via population simulation) Communicate Model-Based Results with DMX® Public Literature Data Summary-level observations Modeling of Competitors, Placebo (Disease) Predictions of NCE and competitor product profiles Software to explore modeling and simulation results
Extensions of CUI Slide 33 © Tripos, L.P. All Rights Reserved
Page 1 and 2: The Clinical Utility Index, a Metho
Page 3 and 4: MOTIVATION Slide 3 © Tripos, L.P.
Page 5 and 6: Motivation - Each drug has a list o
Page 7 and 8: Motivation - ―What is so?‖ vers
Page 9 and 10: INTRODUCTION TO THE CUI Slide 9 ©
Page 11 and 12: Utility The Clinical Utility Index
Page 13 and 14: The underpinnings of CUI are severa
Page 15 and 16: The CUI is an additive multivariate
Page 17 and 18: Construction of a CUI function take
Page 19 and 20: Construction of a CUI function take
Page 21 and 22: CASE STUDY Slide 21 © Tripos, L.P.
Page 23 and 24: SES (cfb) SES (cfb) We explored the
Page 25 and 26: CUI allowed us to link our pharmaco
Page 27 and 28: The Clinical Utility Index reduces
Page 29 and 30: Putting CUI into Practice A relativ
Page 31: BACKUP Slide 31 © Tripos, L.P. All

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