PL EN

FDA: Standards for Clinical Trial Imaging Endpoints.

06.09.2011
The purpose of this guidance is to assist sponsors in the use of endpoints that depend on the results of imaging tests in clinical trials of therapeutic drugs and biological products.2 This guidance focuses on the imaging standards that we regard as important when imaging is used to assess a primary endpoint, or an endpoint component, in a clinical trial intended to confirm a drug’s efficacy.

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