The Challenges and Opportunities
CNS Drug Development is difficult and costly because so many candidates fail in drug development. This chapter addresses the issue and asks whether functional imaging can provide new avenues to evaluating an objective index for drug effects and disease state. We provide an overview of specific domains in which functional imaging may be useful, including (1) dosing, (2) improved efficacy, (3) better animal–human translation (4) evaluation of direct effects of drugs on CNS, (5) pharmaco-phenotype (6) clinical phenotype (7) surrogate models and (8) potential for suggesting or defining new indications based on brain system effects. While the potential seems enormous, the adoption of new imaging technologies in drug development requires evidence-based data.
KeywordsDrug Development Target Engagement Gray Matter Loss Human Translation Traditional Clinical Trial
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