1 / 1

Topics for Discussion

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

darryl
Download Presentation

Topics for Discussion

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related