Thursday 16 October, 2025
Objectives: Provide an overview of the use of quantitative BRA by the FDA. Illustrate how quantitative BRA is undertaken by…
Read moreOral: Benefit-Risk assessment
Overview and implementation of multi criteria decision analysis (MCDA) for benefit-risk assessment
Thursday 16 October, 2025
Overview/Description of presentation: Health care decisions are complex and involve confronting trade-offs between multiple, often conflicting, objectives. Multiple criteria decision…
Read moreEuropean regulatory views on benefit-risk assessment methodologies – role of MCDA and other model-based approaches
Thursday 16 October, 2025
Objectives: Provide an overview of the current benefit/risk assessment process of drug evaluation in the EU Describe past and ongoing…
Read moreSimulation analysis of absolute lymphocytes counts (ALC) and relapse rate (RR) following cladribine (re-)treatment rules in subjects with relapsing-remitting multiple sclerosis (RRMS)
Thursday 16 October, 2025
Objectives: Cladribine’s mechanism of action in RRMS involves lymphocytes. Treatment guidelines aimed at decreasing the risk of developing severe sustained lymphopenia…
Read moreModel-Informed Drug Development (MIDD) for ixazomib, an oral proteasome inhibitor
Thursday 16 October, 2025
Objectives: Ixazomib is approved in the US, EU, Canada, Australia, Venezuela, Israel, Singapore, and Switzerland, in combination with lenalidomide-dexamethasone (Rd), for…
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