| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 10556248 | Journal of Proteomics | 2011 | 9 Pages |
Abstract
⺠Overview of FDA regulation pathways on in vitro diagnostic tests. ⺠Overview of mass spectrometry technology and potential concerns for translation to clinical diagnostics. ⺠Regulatory requirements for premarket submissions and considerations applicable to proteomic assays.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Jinong Li, Kellie B. Kelm, Zivana Tezak,