Building a roadmap to biomarker qualification: challenges and opportunities.

  title={Building a roadmap to biomarker qualification: challenges and opportunities.},
  author={Shashi Amur and Sarmistha Sanyal and Aloka G Chakravarty and Marianne H Noone and James L Kaiser and S K Mccune and ShaAvhree Y Buckman-Garner},
  journal={Biomarkers in medicine},
  volume={9 11},
The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a… CONTINUE READING
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