Model-Informed Drug Development in Neurodegenerative Diseases for Clinical & Regulatory Decisions
Time: 9:00 am
day: Conference Day Two AM
Details:
- MIDD becomes increasingly important in drug development which has been recognized by regulatory agencies around the world. Recently a draft of ICH M15 guideline has been released describing strategic use of modeling and simulation methods that integrate nonclinical and clinical data, prior information, and knowledge to generate evidence.
- Modeling approaches were successfully used in developing new therapies for Alzheimer Disease to describe pathological changes over disease course, enable clinical prediction, aid in disease mechanism understanding, inform clinical trial design and support regulatory decisions.
- This presentation will go over several examples of the use of modeling approaches to inform drug development in AD and PD.
