Building a roadmap to biomarker qualification: challenges and opportunities
| Autor: | Sarmistha Sanyal, Marianne H Noone, Susan McCune, James Kaiser, ShaAvhrée Buckman-Garner, Aloka Chakravarty, Shashi Amur |
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| Rok vydání: | 2015 |
| Předmět: |
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Clinical Trials as Topic Internationality business.industry Statistics as Topic Biochemistry (medical) Clinical Biochemistry Context (language use) Social Control Formal Engineering management Drug development BQP Drug Discovery Drug approval Humans Medicine Biomarker (medicine) Regulatory science Public Health International harmonization Child business Biomarkers |
| Zdroj: | Biomarkers in Medicine. 9:1095-1105 |
| ISSN: | 1752-0371 1752-0363 |
| Popis: | 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 biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program. |
| Databáze: | OpenAIRE |
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