Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.

摘要: The discovery, development, and use of biomarkers for a variety drug development purposes are areas tremendous interest need. Biomarkers can become accepted through submission biomarker data during the approval process. Another emerging pathway acceptance is via qualification program developed by Center Drug Evaluation Research (CDER, US Food Administration). Evidentiary standards needed to develop evaluate various types their intended multiple stakeholders, including academia, industry, government, consortia must work together help this evidence. article describes that be useful in evidentiary considerations important qualification. A path forward coordinating efforts identify explore proposed consideration.