Proteomics quality and standard: from a regulatory perspective.
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ABSTRACT:
SUBMITTER: Gu Q
PROVIDER: S-EPMC8463138 | biostudies-literature | 2014 Jan
REPOSITORIES: biostudies-literature
Publications
Proteomics quality and standard: from a regulatory perspective.
Journal of proteomics 20131204
Proteomics has emerged as a rapidly expanding field dealing with large-scale protein analyses. It is anticipated that proteomics data will be increasingly submitted to the U.S. Food and Drug Administration (FDA) for biomarker qualification or in conjunction with applications for the approval of drugs, medical devices, and other FDA-regulated consumer products. To date, however, no established guideline has been available regarding the generation, submission and assessment of the quality of prote ...[more]
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