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Topics for Discussion

Topics for Discussion. 1. Regulations allow granting regular or accelerated approval

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Topics for Discussion

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  1. Topics for Discussion 1. Regulations allow granting regular or accelerated approval to a drug after demonstration of safety and efficacy. Considering these two situations, discuss the clinical states in which PSA based end points should be evaluated for use in clinical trials to provide evidence to support either type of drug approval.2. Considering that several PSA based end points are possible, discuss the approach to select the end points for further study in prospective clinical trials. 3. Discuss the optimal approach for validation of PSA based end points to allow their eventual use for demonstration of ultimate clinical benefit.

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