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Radiology, ISSN 0033-8419, 06/2011, Volume 259, Issue 3, pp. 875 - 884
Journal Article
PloS one, ISSN 1932-6203, 2013, Volume 8, Issue 1, p. e53733
Journal Article
Experimental Biology and Medicine, ISSN 1535-3702, 2/2018, Volume 243, Issue 3, pp. 256 - 261
.... the 21st Century Cures Act). In addition to these qualification processes, diagnostic tests that measure a biomarker may follow a process for regulatory... 
Biomarkers | qualification | diagnostic | drugs | Food and Drug Administration | validation | MEDICINE, RESEARCH & EXPERIMENTAL | SURROGATE END-POINTS | INTERFACE | DRUG DEVELOPMENT | FRAMEWORK | Diagnostic Tests, Routine | United States | Humans | United States Food and Drug Administration - legislation & jurisprudence | Biomarkers - analysis | Minireview
Journal Article
Clinical chemistry (Baltimore, Md.), ISSN 0009-9147, 2013, Volume 59, Issue 1, pp. 32 - 34
... clinical laboratory test. PCA3 was first described as DD3 in 1999 by Bussemakers and colleagues (1). Researchers in the Isaacs laboratory at Johns Hopkins University... 
PCA3 | DIAGNOSIS | MOLECULAR URINE TEST | ASSAY | PERFORMANCE | MEN | VALIDATION | RISK | MEDICAL LABORATORY TECHNOLOGY | DD3(PCA3) | Male | Prostatic Neoplasms - diagnosis | United States | Humans | Reagent Kits, Diagnostic | United States Food and Drug Administration | Diagnosis | Laws, regulations and rules | Prostate cancer | Cancer | Studies | Clinical trials | Pharmaceutical industry | Laboratories
Journal Article
Journal Article
JAMA : the journal of the American Medical Association, ISSN 0098-7484, 03/2019, Volume 321, Issue 9, pp. 827 - 827
The FDA has approved the first test designed to help diagnose a sexually transmitted infection caused by the Mycoplasma genitalium bacterium... 
MEDICINE, GENERAL & INTERNAL | Sexually transmitted diseases--STD | Infections | Diagnostic systems | FDA approval | Laboratory methods | Antibiotics
Journal Article
2012, 1st ed., ISBN 9780123919113, xxxiii, 638
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial... 
Clinical trials | Medicine: General Issues | Drugs | Testing
Book