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Seminars in Oncology

Volumn 29, Issue 3, 2002, Pages 294-300

Regulatory issues in tumor marker development

(1) Gutman, Steven a,b

a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (United States)

b CENTER FOR DRUG EVALUATION AND RESEARCH (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA FETOPROTEIN; CARCINOEMBRYONIC ANTIGEN; ESTROGEN RECEPTOR; ONCOPROTEIN; PROGESTERONE RECEPTOR; PROSTATE SPECIFIC ANTIGEN; TUMOR MARKER;

ARTICLE; CANCER DIAGNOSIS; DEVICE; DIAGNOSTIC KIT; FOOD AND DRUG ADMINISTRATION; HUMAN; IN VITRO STUDY; LABORATORY TEST; MARKETING; PRIORITY JOURNAL; PUBLIC HEALTH; REGISTRATION; UNITED STATES;

EID: 0036275788 PISSN: 00937754 EISSN: None Source Type: Journal
DOI: 10.1053/sonc.2002.33140 Document Type: Article

Times cited : (14)

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3
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- Comparing methods of measurement: Why plotting difference against standard method is misleading
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- Bland, J.M.¹ Altman, D.G.²

4
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- NCCLS document EP5-A
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5
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- NCCLS document EP9-A
- (1995) Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline

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- NCCLS document EP10-A
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- NCCLS document EP14-A
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8
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- Medical devices; classification/reclassification; restricted devices; analyte specific reagents
- (1997) Federal Register , vol.62 , pp. 62243-62260

9
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- FDA Modernization Act. Pub L No. 105-115, 111 Stat 2296, 1997

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.