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Clinical development program design

Two key resources for input into the design of a successful clinical development program are the corresponding therapeutic FDA Guidance (25,26) and the publicly available reviews by FDA reviewers for... [Pg.505]

Whatever the differentiating feature is, both the drug discovery and the clinical development programs need to be designed to demonstrate the specific differ-entiation(s) that can be incorporated in the drug label and in product advertising. [Pg.507]

Clinical development programs consist of a variety of preapproval clinical trials, all designed for a specific purpose of revealing particular information concerning the investigational drug s safety and efficacy. [Pg.15]

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