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- Title
Industry Perspective on Biomarker Development and Qualification.
- Authors
Gerlach, Cory V.; Derzi, Mazin; Ramaiah, Shashi K.; Vaidya, Vishal S.
- Abstract
Pharmaceutical and biotechnology companies routinely use biomarkers to obtain quantitative metrics for drug exposure, efficacy, and safety and to inform clinical trial design with regard to patient selection, treatments, and outcomes. Biomarker science has the unique capability to catalyze precompetitive collaborations between academia, industry, regulatory agencies, and other stakeholders with the ultimate goal of accelerating the delivery of safe and effective medicines to patients, particularly in areas of high unmet need.
- Subjects
DRUG development; BIOMARKERS; BIOTECHNOLOGY; DRUG efficacy; CLINICAL trials
- Publication
Clinical Pharmacology & Therapeutics, 2018, Vol 103, Issue 1, p27
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1002/cpt.919