Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease
Abstract
Background: Regulatory qualification of a biomarker for a defined context of use provides scientifically robustassurances to sponsors and regulators that accelerate appropriate adoption of biomarkers into drug development. Methods: The Coalition Against Major Diseases submitted a dossier to the Scientific Advice Working Party of the European Medicines Agency requesting a qualification opinion on the use of...
Paper Details
Title
Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease
Published Date
Jul 1, 2014
Journal
Volume
10
Issue
4
Pages
421 - 429
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Notes
History