Modeling and Simulation Supports Competitive Dose

Assessment and go/no go decision in Alzheimer’s Disease modeling strategy provided sponsor with rational basis for product profile evaluation to avoid placing non-competitive dose into Phase III, saving $85 Million and redirecting resources towards other programs

A global pharmaceutical company was seeking to advance its drug candidate, indicated for symptomatic treatment for Alzheimer’s Disease (AD), into pivotal Phase III trials. Data from Phase I and II studies were available on the drug candidate, including Phase IIa and IIb safety and efficacy studies in AD patients.

As the sponsor prepared its pivotal trial strategy, it became critical to provide a rational basis for Phase III dose selection and to establish a comprehensive picture of the drug candidate’s efficacy profile versus Aricept® (donepezil), the “gold standard” treatment for AD.

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