Accelerating CNS Drug Development

Why do we want to accelerate development?; what causes development to stagger?; how much animal data is necessary before exposure to man?; toxicity; efficacy in animal models: is it necessary?; the role of PK/bioavailability studies; dose models: animal models can be poorly predictive of dose; useful in some indications, but not in others; surrogate endpoints; how do you prove the drug is useful? How do you choose the correct dose?; role of the investigator study - does this accelerate development?; must every trial be a placebo-controlled, double-blind, parallel group design?; review of clinical trial design; rationale for selection of initial doses (based on preclinical NTEL or Phase I studies in healthy subjects); methodology of the bridging study: definition of the MTD, recommended design; regulatory issues; are two or more pivotal efficacy studies necessary?; carcinogenicity trials - are long-term studies necessary?; how many years of human exposure are required?; FDA registry parts E and F: have they made a difference?; role of post-marketing data in drug development; concluding remarks on drug development.