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Volumn 24, Issue 8, 2006, Pages 971-983

Protein biomarker discovery and validation: The long and uncertain path to clinical utility

Author keywords

[No Author keywords available]

Indexed keywords

BIOASSAY; DIAGNOSIS; DRUG PRODUCTS; DRUG THERAPY; OPTIMIZATION; PROTEINS;

EID: 33747030845     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt1235     Document Type: Review
Times cited : (1473)

References (121)
  • 1
    • 0038244781 scopus 로고    scopus 로고
    • DNA microarrays in breast cancer: The promise of personalised medicine
    • Ramaswamy, S. & Perou, C.M. DNA microarrays in breast cancer: the promise of personalised medicine. Lancet 361, 1576-1577 (2003).
    • (2003) Lancet , vol.361 , pp. 1576-1577
    • Ramaswamy, S.1    Perou, C.M.2
  • 3
    • 0037648348 scopus 로고    scopus 로고
    • The case for early detection
    • Etzioni, R. et al. The case for early detection. Nat. Rev. Cancer 3, 243-252 (2003).
    • (2003) Nat. Rev. Cancer , vol.3 , pp. 243-252
    • Etzioni, R.1
  • 4
    • 0001644020 scopus 로고    scopus 로고
    • The human plasma proteome: History, character, and diagnostic prospects
    • Anderson, N.L. & Anderson, N.G. The human plasma proteome: history, character, and diagnostic prospects. Mol. Cell. Proteomics 1, 845-867 (2002).
    • (2002) Mol. Cell. Proteomics , vol.1 , pp. 845-867
    • Anderson, N.L.1    Anderson, N.G.2
  • 5
    • 33745560074 scopus 로고    scopus 로고
    • The US Food and Drug Administration perspective on cancer biomarker development
    • Gutman, S. & Kessler, L.G. The US Food and Drug Administration perspective on cancer biomarker development. Nat. Rev. Cancer 6, 565-571 (2006).
    • (2006) Nat. Rev. Cancer , vol.6 , pp. 565-571
    • Gutman, S.1    Kessler, L.G.2
  • 6
    • 27644537898 scopus 로고    scopus 로고
    • The roles of multiple proteomic platforms in a pipeline for new diagnostics
    • Anderson, N.L. The roles of multiple proteomic platforms in a pipeline for new diagnostics. Mol. Cell. Proteomics 4, 1441-1444 (2005).
    • (2005) Mol. Cell. Proteomics , vol.4 , pp. 1441-1444
    • Anderson, N.L.1
  • 7
    • 19644388098 scopus 로고    scopus 로고
    • Serum protein markers for early detection of ovarian cancer
    • Mor, G. et al. Serum protein markers for early detection of ovarian cancer. Proc. Natl. Acad. Sci. USA 102, 7677-7682 (2005).
    • (2005) Proc. Natl. Acad. Sci. USA , vol.102 , pp. 7677-7682
    • Mor, G.1
  • 8
    • 0037117649 scopus 로고    scopus 로고
    • Multimarker approach to risk stratification in non-ST elevation acute coronary syndromes: Simultaneous assessment of troponin I, C-reactive protein, and B-type natriuretic peptide
    • Sabatine, M.S. et al. Multimarker approach to risk stratification in non-ST elevation acute coronary syndromes: simultaneous assessment of troponin I, C-reactive protein, and B-type natriuretic peptide. Circulation 105, 1760-1763 (2002).
    • (2002) Circulation , vol.105 , pp. 1760-1763
    • Sabatine, M.S.1
  • 9
    • 0034425742 scopus 로고    scopus 로고
    • Antibody arrays for high-throughput screening of antibody-antigen interactions
    • de Wildt, R.M., Mundy, C.R., Gorick, B.D. & Tomlinson, I.M. Antibody arrays for high-throughput screening of antibody-antigen interactions. Nat. Biotechnol. 18, 989-994 (2000).
    • (2000) Nat. Biotechnol. , vol.18 , pp. 989-994
    • De Wildt, R.M.1    Mundy, C.R.2    Gorick, B.D.3    Tomlinson, I.M.4
  • 10
    • 0031822837 scopus 로고    scopus 로고
    • Tissue microarrays for high-throughput molecular profiling of tumor specimens
    • Kononen, J. et al. Tissue microarrays for high-throughput molecular profiling of tumor specimens. Nat. Med. 4, 844-847 (1998).
    • (1998) Nat. Med. , vol.4 , pp. 844-847
    • Kononen, J.1
  • 11
    • 0034622925 scopus 로고    scopus 로고
    • Printing proteins as microarrays for high-throughput function determination
    • MacBeath, G. & Schreiber, S.L. Printing proteins as microarrays for high-throughput function determination. Science 289, 1760-1763 (2000).
    • (2000) Science , vol.289 , pp. 1760-1763
    • MacBeath, G.1    Schreiber, S.L.2
  • 12
    • 33645463194 scopus 로고    scopus 로고
    • Multiplexed protein measurement: Technologies and applications of protein and antibody arrays
    • Kingsmore, S.F. Multiplexed protein measurement: technologies and applications of protein and antibody arrays. Nat. Rev. Drug Discov. 5, 310-320 (2006).
    • (2006) Nat. Rev. Drug Discov. , vol.5 , pp. 310-320
    • Kingsmore, S.F.1
  • 13
    • 33645241277 scopus 로고    scopus 로고
    • Array-based proteomics: Mapping of protein circuitries for diagnostics, prognostics, and therapy guidance in cancer
    • Gulmann, C., Sheehan, K.M., Kay, E.W., Liotta, L.A. & Petricoin, E.F., III. Array-based proteomics: mapping of protein circuitries for diagnostics, prognostics, and therapy guidance in cancer. J. Pathol. 208, 595-606 (2006).
    • (2006) J. Pathol. , vol.208 , pp. 595-606
    • Gulmann, C.1    Sheehan, K.M.2    Kay, E.W.3    Liotta, L.A.4    Petricoin III, E.F.5
  • 14
    • 10744226821 scopus 로고    scopus 로고
    • Proteomic profiling of the NCI-60 cancer cell lines using new high-density reverse-phase lysate microarrays
    • Nishizuka, S. et al. Proteomic profiling of the NCI-60 cancer cell lines using new high-density reverse-phase lysate microarrays. Proc. Natl. Acad. Sci. USA 100, 14229-14234 (2003).
    • (2003) Proc. Natl. Acad. Sci. USA , vol.100 , pp. 14229-14234
    • Nishizuka, S.1
  • 15
    • 0035848705 scopus 로고    scopus 로고
    • Reverse phase protein microarrays which capture disease progression show activation of pro-survival pathways at the cancer invasion front
    • Paweletz, C.P. et al. Reverse phase protein microarrays which capture disease progression show activation of pro-survival pathways at the cancer invasion front. Oncogene 20, 1981-1989 (2001).
    • (2001) Oncogene , vol.20 , pp. 1981-1989
    • Paweletz, C.P.1
  • 16
    • 25144483466 scopus 로고    scopus 로고
    • Autoantibody signatures in prostate cancer
    • Wang, X. et al. Autoantibody signatures in prostate cancer. N. Engl. J. Med. 353, 1224-1235 (2005).
    • (2005) N. Engl. J. Med. , vol.353 , pp. 1224-1235
    • Wang, X.1
  • 17
    • 33644524918 scopus 로고    scopus 로고
    • Mass spectrometry-based proteomics turns quantitative
    • Ong, S.E. & Mann, M. Mass spectrometry-based proteomics turns quantitative. Nat. Chem. Biol. 1, 252-262 (2005).
    • (2005) Nat. Chem. Biol. , vol.1 , pp. 252-262
    • Ong, S.E.1    Mann, M.2
  • 18
    • 33644874718 scopus 로고    scopus 로고
    • Metabolomic identification of novel biomarkers of myocardial ischemia
    • Sabatine, M.S. et al. Metabolomic identification of novel biomarkers of myocardial ischemia. Circulation 112, 3868-3875 (2005).
    • (2005) Circulation , vol.112 , pp. 3868-3875
    • Sabatine, M.S.1
  • 19
    • 0003945589 scopus 로고    scopus 로고
    • Burtis, C.A., Ashwood, E.R. & Bruns, D.E. (eds.). Elsevier Saunders Co., Philadelphia
    • Burtis, C.A., Ashwood, E.R. & Bruns, D.E. (eds.). Tietz Textbook of Clinical Chemistry. (Elsevier Saunders Co., Philadelphia, 2005).
    • (2005) Tietz Textbook of Clinical Chemistry
  • 20
    • 0037086181 scopus 로고    scopus 로고
    • Identification of hepatocarcinoma-intestine-pancreas/pancreatitis- associated protein I as a biomarker for pancreatic ductal adenocarcinoma by protein biochip technology
    • Rosty, C. et al. Identification of hepatocarcinoma-intestine-pancreas/ pancreatitis-associated protein I as a biomarker for pancreatic ductal adenocarcinoma by protein biochip technology. Cancer Res. 62, 1868-1875 (2002).
    • (2002) Cancer Res. , vol.62 , pp. 1868-1875
    • Rosty, C.1
  • 21
    • 2542612884 scopus 로고    scopus 로고
    • Proteomic characterization of the interstitial fluid perfusing the breast tumor microenvironment: A novel resource for biomarker and therapeutic target discovery
    • Celis, J.E. et al. Proteomic characterization of the interstitial fluid perfusing the breast tumor microenvironment: a novel resource for biomarker and therapeutic target discovery. Mol. Cell. Proteomics 3, 327-344 (2004).
    • (2004) Mol. Cell. Proteomics , vol.3 , pp. 327-344
    • Celis, J.E.1
  • 22
    • 0036839667 scopus 로고    scopus 로고
    • Comparative analysis of CA125, tissue polypeptide specific antigen, and soluble interleukin-2 receptor alpha levels in sera, cyst, and ascitic fluids from patients with ovarian carcinoma
    • Sedlaczek, P. et al. Comparative analysis of CA125, tissue polypeptide specific antigen, and soluble interleukin-2 receptor alpha levels in sera, cyst, and ascitic fluids from patients with ovarian carcinoma. Cancer 95, 1886-1893 (2002).
    • (2002) Cancer , vol.95 , pp. 1886-1893
    • Sedlaczek, P.1
  • 23
    • 33747047385 scopus 로고    scopus 로고
    • Entertainment Industry Foundation, Women's Cancer Research Fund Breast Cancer Biomarker Discovery Project. http://www.eifoundation.org/national/wcrf/ press/article2005-10-04.html.
  • 24
    • 28544432790 scopus 로고    scopus 로고
    • The differential effects of mutant p53 alleles on advanced murine lung cancer
    • Jackson, E.L. et al. The differential effects of mutant p53 alleles on advanced murine lung cancer. Cancer Res. 65, 10280-10288 (2005).
    • (2005) Cancer Res. , vol.65 , pp. 10280-10288
    • Jackson, E.L.1
  • 25
    • 0030470572 scopus 로고    scopus 로고
    • Neoplastic transformation: The contrasting stability of human and mouse cells
    • Holliday, R. Neoplastic transformation: the contrasting stability of human and mouse cells. Cancer Surv. 28, 103-115 (1996).
    • (1996) Cancer Surv. , vol.28 , pp. 103-115
    • Holliday, R.1
  • 26
    • 0034109921 scopus 로고    scopus 로고
    • Carcinogenesis in mouse and human cells: Parallels and paradoxes
    • Balmain, A. & Harris, C.C. Carcinogenesis in mouse and human cells: parallels and paradoxes. Carcinogenesis 21, 371-377 (2000).
    • (2000) Carcinogenesis , vol.21 , pp. 371-377
    • Balmain, A.1    Harris, C.C.2
  • 27
    • 1942422743 scopus 로고    scopus 로고
    • Of mice and men: Values and liabilities of the athymic nude mouse model in anticancer drug development
    • Kelland, L.R. Of mice and men: values and liabilities of the athymic nude mouse model in anticancer drug development. Eur. J. Cancer 40, 827-836 (2004).
    • (2004) Eur. J. Cancer , vol.40 , pp. 827-836
    • Kelland, L.R.1
  • 28
    • 0141566685 scopus 로고    scopus 로고
    • Clinical predictive value of the in vitro cell line, human xenograft, and mouse allograft preclinical cancer models
    • Voskoglou-Nomikos, T., Pater, J.L. & Seymour, L. Clinical predictive value of the in vitro cell line, human xenograft, and mouse allograft preclinical cancer models. Clin. Cancer Res. 9, 4227-4239 (2003).
    • (2003) Clin. Cancer Res. , vol.9 , pp. 4227-4239
    • Voskoglou-Nomikos, T.1    Pater, J.L.2    Seymour, L.3
  • 29
    • 0035060345 scopus 로고    scopus 로고
    • Unraveling human cancer in the mouse: Recent refinements to modeling and analysis
    • Resor, L., Bowen, T.J. & Wynshaw-Boris, A. Unraveling human cancer in the mouse: recent refinements to modeling and analysis. Hum. Mol. Genet. 10, 669-675 (2001).
    • (2001) Hum. Mol. Genet. , vol.10 , pp. 669-675
    • Resor, L.1    Bowen, T.J.2    Wynshaw-Boris3
  • 30
    • 0037435030 scopus 로고    scopus 로고
    • Mass spectrometry-based proteomics
    • Aebersold, R. & Mann, M. Mass spectrometry-based proteomics. Nature 422, 198-207 (2003).
    • (2003) Nature , vol.422 , pp. 198-207
    • Aebersold, R.1    Mann, M.2
  • 31
    • 0037116832 scopus 로고    scopus 로고
    • Use of proteomic patterns in serum to identify ovarian cancer
    • Petricoin, E.F. et al. Use of proteomic patterns in serum to identify ovarian cancer. Lancet 359, 572-577 (2002).
    • (2002) Lancet , vol.359 , pp. 572-577
    • Petricoin, E.F.1
  • 33
    • 1542617944 scopus 로고    scopus 로고
    • Serum peptide profiling by magnetic particle-assisted, automated sample processing and MALDI-TOF mass spectrometry
    • Villanueva, J. et al. Serum peptide profiling by magnetic particle-assisted, automated sample processing and MALDI-TOF mass spectrometry. Anal. Chem. 76, 1560-1570 (2004).
    • (2004) Anal. Chem. , vol.76 , pp. 1560-1570
    • Villanueva, J.1
  • 34
    • 0036589851 scopus 로고    scopus 로고
    • Integrating "top-down" and "bottom-up" mass spectrometric approaches for proteomic analysis of Shewanella oneidensis
    • VerBerkmoes, N.C. et al. Integrating "top-down" and "bottom-up" mass spectrometric approaches for proteomic analysis of Shewanella oneidensis. J. Proteome Res. 1, 239-252 (2002).
    • (2002) J. Proteome Res. , vol.1 , pp. 239-252
    • VerBerkmoes, N.C.1
  • 35
    • 0003206867 scopus 로고    scopus 로고
    • Toward a human blood serum proteome: Analysis by multidimensional separation coupled with mass spectrometry
    • Adkins, J.N. et al. Toward a human blood serum proteome: analysis by multidimensional separation coupled with mass spectrometry. Mol. Cell. Proteomics 1, 947-955 (2002).
    • (2002) Mol. Cell. Proteomics , vol.1 , pp. 947-955
    • Adkins, J.N.1
  • 36
    • 1242316198 scopus 로고    scopus 로고
    • Ultra-high-efficiency strong cation exchange LC/RPLC/MS/MS for high dynamic range characterization of the human plasma proteome
    • Shen, Y. et al. Ultra-high-efficiency strong cation exchange LC/RPLC/MS/MS for high dynamic range characterization of the human plasma proteome. Anal. Chem. 76, 1134-1144 (2004).
    • (2004) Anal. Chem. , vol.76 , pp. 1134-1144
    • Shen, Y.1
  • 37
    • 0242669999 scopus 로고    scopus 로고
    • High-efficiency on-line solid-phase extraction coupling to 15-150-microm-i.d. column liquid chromatography for proteomic analysis
    • Shen, Y. et al. High-efficiency on-line solid-phase extraction coupling to 15-150-microm-i.d. column liquid chromatography for proteomic analysis. Anal. Chem. 75, 3596-3605 (2003).
    • (2003) Anal. Chem. , vol.75 , pp. 3596-3605
    • Shen, Y.1
  • 38
    • 0346364695 scopus 로고    scopus 로고
    • Characterization of the low molecular weight human serum proteome
    • Tirumalai, R.S. et al. Characterization of the low molecular weight human serum proteome. Mol. Cell. Proteomics 2, 1096-1103 (2003).
    • (2003) Mol. Cell. Proteomics , vol.2 , pp. 1096-1103
    • Tirumalai, R.S.1
  • 39
    • 10744233766 scopus 로고    scopus 로고
    • Quantification of proteins and metabolites by mass spectrometry without isotopic labeling or spiked standards
    • Wang, W. et al. Quantification of proteins and metabolites by mass spectrometry without isotopic labeling or spiked standards. Anal. Chem. 75, 4818-4826 (2003).
    • (2003) Anal. Chem. , vol.75 , pp. 4818-4826
    • Wang, W.1
  • 40
    • 23944490671 scopus 로고    scopus 로고
    • Place of pattern in proteomic biomarker discovery
    • Gillette, M.A., Mani, D.R. & Carr, S.A. Place of pattern in proteomic biomarker discovery. J. Proteome Res. 4, 1143-1154 (2005).
    • (2005) J. Proteome Res. , vol.4 , pp. 1143-1154
    • Gillette, M.A.1    Mani, D.R.2    Carr, S.A.3
  • 41
    • 33645463331 scopus 로고    scopus 로고
    • MapQuant: Open-source software for large-scale protein quantification
    • Leptos, K.C., Sarracino, D.A., Jaffe, J.D., Krastins, B. & Church, G.M. MapQuant: open-source software for large-scale protein quantification. Proteomics 6, 1770-1782 (2006).
    • (2006) Proteomics , vol.6 , pp. 1770-1782
    • Leptos, K.C.1    Sarracino, D.A.2    Jaffe, J.D.3    Krastins, B.4    Church, G.M.5
  • 42
    • 33646264529 scopus 로고    scopus 로고
    • Advances in proteomics data analysis and display using an accurate mass and time tag approach
    • Zimmer, J.S., Monroe, M.E., Qian, W.J. & Smith, R.D. Advances in proteomics data analysis and display using an accurate mass and time tag approach. Mass Spectrom. Rev. 25, 450-482 (2006).
    • (2006) Mass Spectrom. Rev. , vol.25 , pp. 450-482
    • Zimmer, J.S.1    Monroe, M.E.2    Qian, W.J.3    Smith, R.D.4
  • 43
    • 0033565832 scopus 로고    scopus 로고
    • Role of accurate mass measurement (+/- 10 ppm) in protein identification strategies employing MS or MS/MS and database searching
    • Clauser, K.R., Baker, P.R. & Burlingame, A.L. Role of accurate mass measurement (+/- 10 ppm) in protein identification strategies employing MS or MS/MS and database searching. Anal. Chem. 71, 2871-2882 (1999).
    • (1999) Anal. Chem. , vol.71 , pp. 2871-2882
    • Clauser, K.R.1    Baker, P.R.2    Burlingame, A.L.3
  • 44
    • 2342593352 scopus 로고    scopus 로고
    • De novo sequencing, peptide composition analysis, and composition-based sequencing: A new strategy employing accurate mass determination by fourier transform ion cyclotron resonance mass spectrometry
    • Spengler, B. De novo sequencing, peptide composition analysis, and composition-based sequencing: a new strategy employing accurate mass determination by fourier transform ion cyclotron resonance mass spectrometry. J. Am. Soc. Mass Spectrom. 15, 703-714 (2004).
    • (2004) J. Am. Soc. Mass Spectrom. , vol.15 , pp. 703-714
    • Spengler, B.1
  • 45
    • 4544370533 scopus 로고    scopus 로고
    • Improved peptide identification in proteomics by two consecutive stages of mass spectrometric fragmentation
    • Olsen, J.V. & Mann, M. Improved peptide identification in proteomics by two consecutive stages of mass spectrometric fragmentation. Proc. Natl. Acad. Sci. USA 101, 13417-13422 (2004).
    • (2004) Proc. Natl. Acad. Sci. USA , vol.101 , pp. 13417-13422
    • Olsen, J.V.1    Mann, M.2
  • 46
    • 2542640024 scopus 로고    scopus 로고
    • Protein identification by mass spectrometry
    • Baldwin, M.A. Protein identification by mass spectrometry. Mol. Cell. Proteomics 3, 1-9 (2004).
    • (2004) Mol. Cell. Proteomics , vol.3 , pp. 1-9
    • Baldwin, M.A.1
  • 47
    • 3042735127 scopus 로고    scopus 로고
    • The need for guidelines in publication of peptide and protein identification data
    • Carr, S. et al. The need for guidelines in publication of peptide and protein identification data. Mol. Cell. Proteomics 3, 531-533 (2004).
    • (2004) Mol. Cell. Proteomics , vol.3 , pp. 531-533
    • Carr, S.1
  • 48
    • 1042266254 scopus 로고    scopus 로고
    • Analysis, statistical validation and dissemination of large-scale proteomics datasets generated by tandem MS
    • Nesvizhskii, A. & Aebersold, R. Analysis, statistical validation and dissemination of large-scale proteomics datasets generated by tandem MS. Drug Discov. Today 9, 173-181 (2004).
    • (2004) Drug Discov. Today , vol.9 , pp. 173-181
    • Nesvizhskii, A.1    Aebersold, R.2
  • 49
    • 1542617945 scopus 로고    scopus 로고
    • Novel statistical models for protein validation using tandem mass spectral data and protein amino acid sequence databases, analytical chemistry
    • Sadygov, R., Liu, H. & Yates, J.R. Novel statistical models for protein validation using tandem mass spectral data and protein amino acid sequence databases, analytical chemistry. Anal. Chem. 76, 1664-1671 (2004).
    • (2004) Anal. Chem. , vol.76 , pp. 1664-1671
    • Sadygov, R.1    Liu, H.2    Yates, J.R.3
  • 50
    • 33644864034 scopus 로고    scopus 로고
    • Challenges in deriving high-confidence protein identifications from data gathered by a HUPO plasma proteome collaborative study
    • States, D.J. et al. Challenges in deriving high-confidence protein identifications from data gathered by a HUPO plasma proteome collaborative study. Nat. Biotechnol. 24, 333-338 (2006).
    • (2006) Nat. Biotechnol. , vol.24 , pp. 333-338
    • States, D.J.1
  • 51
    • 23944492134 scopus 로고    scopus 로고
    • Overview of the HUPO Plasma Proteome Project: Results from the pilot phase with 35 collaborating laboratories and multiple analytical groups, generating a core dataset of 3020 proteins and a publicly-available database
    • Omenn, G.S. et al. Overview of the HUPO Plasma Proteome Project: results from the pilot phase with 35 collaborating laboratories and multiple analytical groups, generating a core dataset of 3020 proteins and a publicly-available database. Proteomics 5, 3226-3245 (2005).
    • (2005) Proteomics , vol.5 , pp. 3226-3245
    • Omenn, G.S.1
  • 52
    • 0032190378 scopus 로고    scopus 로고
    • Protein identification at the low femtomole level from silver-stained gels using a new fritless electrospray interface for liquid chromatography- microspray and nanospray mass spectrometry
    • Gatlin, C.L., Kleemann, G.R., Hays, L.G., Link, A.J. & Yates, J.R., III. Protein identification at the low femtomole level from silver-stained gels using a new fritless electrospray interface for liquid chromatography-microspray and nanospray mass spectrometry. Anal. Biochem. 263, 93-101 (1998).
    • (1998) Anal. Biochem. , vol.263 , pp. 93-101
    • Gatlin, C.L.1    Kleemann, G.R.2    Hays, L.G.3    Link, A.J.4    Yates III, J.R.5
  • 53
    • 13844271209 scopus 로고    scopus 로고
    • Informatics for protein identification by mass spectrometry
    • Johnson, R.S., Davis, M.T., Taylor, J.A. & Patterson, S.D. Informatics for protein identification by mass spectrometry. Methods 35, 223-236 (2005).
    • (2005) Methods , vol.35 , pp. 223-236
    • Johnson, R.S.1    Davis, M.T.2    Taylor, J.A.3    Patterson, S.D.4
  • 54
    • 18744398125 scopus 로고    scopus 로고
    • Large-scale database searching using tandem mass spectra: Looking up the answer in the back of the book
    • Sadygov, R.G., Cociorva, D. & Yates, J.R., III. Large-scale database searching using tandem mass spectra: looking up the answer in the back of the book. Nat. Methods 1, 195-202 (2004).
    • (2004) Nat. Methods , vol.1 , pp. 195-202
    • Sadygov, R.G.1    Cociorva, D.2    Yates III, J.R.3
  • 55
    • 0033128171 scopus 로고    scopus 로고
    • LC/MS applications in drug development
    • Lee, M.S. & Kerns, E.H. LC/MS applications in drug development. Mass Spectrom. Rev. 18, 187-279 (1999).
    • (1999) Mass Spectrom. Rev. , vol.18 , pp. 187-279
    • Lee, M.S.1    Kerns, E.H.2
  • 56
    • 0019982067 scopus 로고
    • Structural elucidation of drug metabolites by triple-quadrupole mass spectrometry
    • Perchalski, R., Yost, R. & Wilder, B. Structural elucidation of drug metabolites by triple-quadrupole mass spectrometry. Anal. Chem. 54, 1466-1471 (1982).
    • (1982) Anal. Chem. , vol.54 , pp. 1466-1471
    • Perchalski, R.1    Yost, R.2    Wilder, B.3
  • 57
    • 0030979247 scopus 로고    scopus 로고
    • Drug quantitation on a benchtop liquid chromatograpy-tandem mass spectrometry system
    • Tiller, P. et al. Drug quantitation on a benchtop liquid chromatograpy-tandem mass spectrometry system. J. Chromatogr. A. 771, 119-125 (1997b).
    • (1997) J. Chromatogr. A , vol.771 , pp. 119-125
    • Tiller, P.1
  • 58
    • 0032562528 scopus 로고    scopus 로고
    • Quantitative liquid chromatographic-tandem mass spectrometric determination of orlistat in plasma with a quadrupole ion trap
    • Wieboldt, R., Campbell, D. & Henion, J. Quantitative liquid chromatographic-tandem mass spectrometric determination of orlistat in plasma with a quadrupole ion trap. J. Chromatogr. B Biomed. Sci. Appl. 708, 121-129 (1998).
    • (1998) J. Chromatogr. B Biomed. Sci. Appl. , vol.708 , pp. 121-129
    • Wieboldt, R.1    Campbell, D.2    Henion, J.3
  • 59
    • 84986850849 scopus 로고
    • Tandem mass spectrometry (MS/MS) instrumentation
    • Yost, R.A. & Fetterolf, D.D. Tandem mass spectrometry (MS/MS) instrumentation. Mass Spectrom. Rev. 2, 1-45 (1983).
    • (1983) Mass Spectrom. Rev. , vol.2 , pp. 1-45
    • Yost, R.A.1    Fetterolf, D.D.2
  • 60
    • 0000376535 scopus 로고    scopus 로고
    • Peptide quantification by tandem mass spectrometry
    • Zhu, X. & Desiderio, D. Peptide quantification by tandem mass spectrometry, Mass Spectrom. Rev. 15, 213-240 (1996).
    • (1996) Mass Spectrom. Rev. , vol.15 , pp. 213-240
    • Zhu, X.1    Desiderio, D.2
  • 61
    • 0346059333 scopus 로고    scopus 로고
    • Advances in analytical mass spectrometry to improve screening for inherited metabolic diseases
    • Roschinger, W., Olgemoller, B., Fingerhut, R., Liebl, B. & Roscher, A. Advances in analytical mass spectrometry to improve screening for inherited metabolic diseases. Eur. J. Pediatr. 162, S67-S76 (2003).
    • (2003) Eur. J. Pediatr. , vol.162
    • Roschinger, W.1    Olgemoller, B.2    Fingerhut, R.3    Liebl, B.4    Roscher, A.5
  • 62
    • 0020807419 scopus 로고
    • Preparation of stable-isotope incorporated peptide internal standards for field desorption mass spectrometry quantification of peptides in biologic tissue
    • Desiderio, D. & Kai, M. Preparation of stable-isotope incorporated peptide internal standards for field desorption mass spectrometry quantification of peptides in biologic tissue. Biomed. Mass Spectrom. 1983, 471-479 (1983).
    • (1983) Biomed. Mass Spectrom. , vol.1983 , pp. 471-479
    • Desiderio, D.1    Kai, M.2
  • 63
    • 0021284718 scopus 로고
    • Measurement of enkephalin peptides in canine brain regions, teeth, and CSF with HPLC and mass spectrometry
    • Desiderio, D., Kai, M., Tanzer, F., Trimble, J. & Wakelyn, C. Measurement of enkephalin peptides in canine brain regions, teeth, and CSF with HPLC and mass spectrometry. J. Chromatogr. 297, 245-260 (1984).
    • (1984) J. Chromatogr. , vol.297 , pp. 245-260
    • Desiderio, D.1    Kai, M.2    Tanzer, F.3    Trimble, J.4    Wakelyn5
  • 64
    • 10244256354 scopus 로고    scopus 로고
    • Isotope-dilution mass spectrometric quantification of specific proteins: Model application with apolipoprotein A-1
    • Barr, J. et al. Isotope-dilution mass spectrometric quantification of specific proteins: model application with apolipoprotein A-1. Clin. Chem. 42, 1676-1682 (1996).
    • (1996) Clin. Chem. , vol.42 , pp. 1676-1682
    • Barr, J.1
  • 65
    • 0037795741 scopus 로고    scopus 로고
    • Absolute quantification of proteins and phosphoproteins from cell lysates by tandem MS
    • Gerber, S.A., Rush, J., Stemman, O., Kirschner, M.W. & Gygi, S.P. Absolute quantification of proteins and phosphoproteins from cell lysates by tandem MS. Proc. Natl. Acad. Sci. USA 100, 6940-6945 (2003).
    • (2003) Proc. Natl. Acad. Sci. USA , vol.100 , pp. 6940-6945
    • Gerber, S.A.1    Rush, J.2    Stemman, O.3    Kirschner, M.W.4    Gygi, S.P.5
  • 66
    • 1842528125 scopus 로고    scopus 로고
    • Quantification of C-reactive protein in the serum of patients with rheumatoid arthritis using multiple reaction monitoring mass spectrometry and 13C-labeled peptide standards
    • Kuhn, E. et al. Quantification of C-reactive protein in the serum of patients with rheumatoid arthritis using multiple reaction monitoring mass spectrometry and 13C-labeled peptide standards. Proteomics 4, 1175-1186 (2004).
    • (2004) Proteomics , vol.4 , pp. 1175-1186
    • Kuhn, E.1
  • 67
    • 0036767470 scopus 로고    scopus 로고
    • Targeted proteomics of low-level proteins in human plasma by LC/MSn: Using human growth hormone as a model system
    • Wu, S. et al. Targeted proteomics of low-level proteins in human plasma by LC/MSn: using human growth hormone as a model system. J. Proteome Res. 1, 459-465 (2002).
    • (2002) J. Proteome Res. , vol.1 , pp. 459-465
    • Wu, S.1
  • 68
    • 4444301306 scopus 로고    scopus 로고
    • Absolute quantification of the model biomarker prostate-specific antigen in serum by LC-MS/MS using protein cleavage and isotope dilution MS
    • Barnidge, D., Goodmanson, M., Klee, G. & Muddiman, D. Absolute quantification of the model biomarker prostate-specific antigen in serum by LC-MS/MS using protein cleavage and isotope dilution MS. J. Proteome Res. 3, 644-652 (2004).
    • (2004) J. Proteome Res. , vol.3 , pp. 644-652
    • Barnidge, D.1    Goodmanson, M.2    Klee, G.3    Muddiman, D.4
  • 69
    • 33645721632 scopus 로고    scopus 로고
    • Quantitative mass spectrometric multiple reaction monitoring assays for major plasma proteins
    • Anderson, L. & Hunter, C.L. Quantitative mass spectrometric multiple reaction monitoring assays for major plasma proteins. Mol. Cell. Proteomics 5, 573-588 (2006).
    • (2006) Mol. Cell. Proteomics , vol.5 , pp. 573-588
    • Anderson, L.1    Hunter, C.L.2
  • 70
    • 8844233567 scopus 로고    scopus 로고
    • Mass spectrometric quantitation of peptides and proteins using stable isotope standards and capture by anti-peptide antibodies (SISCAPA)
    • Anderson, N.L. et al. Mass spectrometric quantitation of peptides and proteins using stable isotope standards and capture by anti-peptide antibodies (SISCAPA). J. Proteome Res. 3, 235-244 (2004).
    • (2004) J. Proteome Res. , vol.3 , pp. 235-244
    • Anderson, N.L.1
  • 71
    • 23944436422 scopus 로고    scopus 로고
    • Proteomics: From basic research to diagnostic application. a review of requirements & needs
    • Vitzthum, F., Behrens, F., Anderson, N.L. & Shaw, J.H. Proteomics: from basic research to diagnostic application. A review of requirements & needs. J. Proteome Res. 4, 1086-1097 (2005).
    • (2005) J. Proteome Res. , vol.4 , pp. 1086-1097
    • Vitzthum, F.1    Behrens, F.2    Anderson, N.L.3    Shaw, J.H.4
  • 74
    • 0037226924 scopus 로고    scopus 로고
    • Commutability of the CRM 470 C-reactive protein value in the Dade Behring N High Sensitivity CRP assay
    • Johnson, A.M., Ledue, T.B. & Collins, M.F. Commutability of the CRM 470 C-reactive protein value in the Dade Behring N High Sensitivity CRP assay. Clin. Chem. Lab. Med. 41, 177-182 (2003).
    • (2003) Clin. Chem. Lab. Med. , vol.41 , pp. 177-182
    • Johnson, A.M.1    Ledue, T.B.2    Collins, M.F.3
  • 75
    • 0035210809 scopus 로고    scopus 로고
    • Protein standardization IV: Value transfer procedure for the assignment of serum protein values from a reference preparation to a target material
    • Blirup-Jensen, S., Johnson, A.M. & Larsen, M. Protein standardization IV: value transfer procedure for the assignment of serum protein values from a reference preparation to a target material. Clin. Chem. Lab. Med. 39, 1110-1122 (2001).
    • (2001) Clin. Chem. Lab. Med. , vol.39 , pp. 1110-1122
    • Blirup-Jensen, S.1    Johnson, A.M.2    Larsen, M.3
  • 76
    • 0034033065 scopus 로고    scopus 로고
    • Standardization activities for harmonization of test results
    • Dati, F. & Brand, B. Standardization activities for harmonization of test results. Clin. Chim. Acta 297, 239-249 (2000).
    • (2000) Clin. Chim. Acta , vol.297 , pp. 239-249
    • Dati, F.1    Brand, B.2
  • 77
    • 23444453074 scopus 로고    scopus 로고
    • Multiplexed analysis of biomarkers related to obesity and the metabolic syndrome in human plasma, using the Luminex-100 system
    • Liu, M.Y. et al. Multiplexed analysis of biomarkers related to obesity and the metabolic syndrome in human plasma, using the Luminex-100 system. Clin. Chem. 51, 1102-1109 (2005).
    • (2005) Clin. Chem. , vol.51 , pp. 1102-1109
    • Liu, M.Y.1
  • 78
    • 0032964670 scopus 로고    scopus 로고
    • Analytical performance characteristics should be judged against objective quality specifications
    • Fraser, C.G. & Petersen, P.H. Analytical performance characteristics should be judged against objective quality specifications. Clin. Chem. 45, 321-323 (1999).
    • (1999) Clin. Chem. , vol.45 , pp. 321-323
    • Fraser, C.G.1    Petersen, P.H.2
  • 79
    • 0030932213 scopus 로고    scopus 로고
    • Vocabulary for use in measurement procedures and description of reference materials in laboratory medicine
    • Dybkaer, R. Vocabulary for use in measurement procedures and description of reference materials in laboratory medicine. Eur. J. Clin. Chem. Clin. Biochem. 35, 141-173 (1997).
    • (1997) Eur. J. Clin. Chem. Clin. Biochem. , vol.35 , pp. 141-173
    • Dybkaer, R.1
  • 81
    • 0027414009 scopus 로고
    • Evaluation of regression procedures for methods comparison studies
    • Linnet, K. Evaluation of regression procedures for methods comparison studies. Clin. Chem. 39, 424-432 (1993).
    • (1993) Clin. Chem. , vol.39 , pp. 424-432
    • Linnet, K.1
  • 82
    • 84908219488 scopus 로고
    • Statistical methods for assessing agreement between two methods of clinical measurement
    • Bland, J.M. & Altman, D.G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1, 307-310 (1986).
    • (1986) Lancet , vol.1 , pp. 307-310
    • Bland, J.M.1    Altman, D.G.2
  • 84
    • 0023853204 scopus 로고
    • Heterophilic antibodies: A problem for all immunoassays
    • Boscato, L.M. & Stuart, M.C. Heterophilic antibodies: a problem for all immunoassays. Clin. Chem. 34, 27-33 (1988).
    • (1988) Clin. Chem. , vol.34 , pp. 27-33
    • Boscato, L.M.1    Stuart, M.C.2
  • 85
    • 0032814344 scopus 로고    scopus 로고
    • Human anti-animal antibody interferences in immunological assays
    • Kricka, L.J. Human anti-animal antibody interferences in immunological assays. Clin. Chem. 45, 942-956 (1999).
    • (1999) Clin. Chem. , vol.45 , pp. 942-956
    • Kricka, L.J.1
  • 87
    • 0027413476 scopus 로고
    • College of American Pathologists Conference XXIII on matrix effects and accuracy assessment in clinical chemistry: Introduction
    • Miller, W.G. & Kaufman, H.W. College of American Pathologists Conference XXIII on matrix effects and accuracy assessment in clinical chemistry: introduction. Arch. Pathol. Lab. Med. 117, 343-344 (1993).
    • (1993) Arch. Pathol. Lab. Med. , vol.117 , pp. 343-344
    • Miller, W.G.1    Kaufman, H.W.2
  • 90
    • 84898982319 scopus 로고
    • Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC Recommendations 1995)
    • Currie, L. Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC Recommendations 1995). Pure Appl. Chem. 67, 1699-1723 (1995).
    • (1995) Pure Appl. Chem. , vol.67 , pp. 1699-1723
    • Currie, L.1
  • 93
    • 0023335944 scopus 로고
    • Approved recommendation (1986) on the theory of reference values. Part 1. The concept of reference values
    • International Federation of Clinical Chemistry (IFCC), Scientific Committee, Clinical Section, Expert Panel on Theory of Reference Values, and International Committee for Standardization in Haematology (ICSH), Standing Committee on Reference Values
    • Solberg, H.E. International Federation of Clinical Chemistry (IFCC), Scientific Committee, Clinical Section, Expert Panel on Theory of Reference Values, and International Committee for Standardization in Haematology (ICSH), Standing Committee on Reference Values. Approved recommendation (1986) on the theory of reference values. Part 1. The concept of reference values. J. Clin. Chem. Clin. Biochem. 25, 337-342 (1987).
    • (1987) J. Clin. Chem. Clin. Biochem. , vol.25 , pp. 337-342
    • Solberg, H.E.1
  • 94
    • 0024083517 scopus 로고
    • Approved recommendation (1988) on the theory of reference values. Part 3. Preparation of individuals and collection of specimens for the production of reference values
    • International Federation of Clinical Chemistry (IFCC), Scientific Committee, Clinical Section, Expert Panel on Theory of Reference Values
    • Solberg, H.E. & PetitClerc, C. International Federation of Clinical Chemistry (IFCC), Scientific Committee, Clinical Section, Expert Panel on Theory of Reference Values. Approved recommendation (1988) on the theory of reference values. Part 3. Preparation of individuals and collection of specimens for the production of reference values. J. Clin. Chem. Clin. Biochem. 26, 593-598 (1988).
    • (1988) J. Clin. Chem. Clin. Biochem. , vol.26 , pp. 593-598
    • Solberg, H.E.1    PetitClerc, C.2
  • 96
    • 0025191145 scopus 로고
    • On dividing reference data into subgroups to produce separate reference ranges
    • Harris, E.K. & Boyd, J.C. On dividing reference data into subgroups to produce separate reference ranges. Clin. Chem. 36, 265-270 (1990).
    • (1990) Clin. Chem. , vol.36 , pp. 265-270
    • Harris, E.K.1    Boyd, J.C.2
  • 97
    • 0021014077 scopus 로고
    • The theory of reference values Part 5. Statistical treatment of collected reference values. Determination of reference limits
    • Solberg, H.E. The theory of reference values Part 5. Statistical treatment of collected reference values. Determination of reference limits. J. Clin. Chem. Clin. Biochem. 21, 749-760 (1983).
    • (1983) J. Clin. Chem. Clin. Biochem. , vol.21 , pp. 749-760
    • Solberg, H.E.1
  • 98
    • 0036910739 scopus 로고    scopus 로고
    • European Society of Cardiology and American College of Cardiology guidelines for redefinition of myocardial infarction: How to use existing assays clinically and for clinical trials
    • Apple, F.S., Wu, A.H. & Jaffe, A.S. European Society of Cardiology and American College of Cardiology guidelines for redefinition of myocardial infarction: how to use existing assays clinically and for clinical trials. Am. Heart J. 144, 981-986 (2002).
    • (2002) Am. Heart J. , vol.144 , pp. 981-986
    • Apple, F.S.1    Wu, A.H.2    Jaffe, A.S.3
  • 99
    • 0035897696 scopus 로고    scopus 로고
    • Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)
    • Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). J. Am. Med. Assoc. 285, 2486-2497 (2001).
    • (2001) J. Am. Med. Assoc. , vol.285 , pp. 2486-2497
  • 100
    • 0026768614 scopus 로고
    • Nocturnal plasma levels of cytokines in healthy men
    • Gudewill, S. et al. Nocturnal plasma levels of cytokines in healthy men. Eur. Arch. Psychiatry Clin. Neurosci. 242, 53-56 (1992).
    • (1992) Eur. Arch. Psychiatry Clin. Neurosci. , vol.242 , pp. 53-56
    • Gudewill, S.1
  • 101
    • 0035103617 scopus 로고    scopus 로고
    • Absence of diurnal variation of C-reactive protein concentrations in healthy human subjects
    • Meier-Ewert, H.K. et al. Absence of diurnal variation of C-reactive protein concentrations in healthy human subjects. Clin. Chem. 47, 426-430 (2001).
    • (2001) Clin. Chem. , vol.47 , pp. 426-430
    • Meier-Ewert, H.K.1
  • 103
    • 0025365742 scopus 로고
    • Reevaluation of serum-plasma differences in total cholesterol concentration
    • Cloey, T. et al. Reevaluation of serum-plasma differences in total cholesterol concentration. J. Am. Med. Assoc. 263, 2788-2789 (1990).
    • (1990) J. Am. Med. Assoc. , vol.263 , pp. 2788-2789
    • Cloey, T.1
  • 104
    • 20244384861 scopus 로고    scopus 로고
    • Future biomarkers for detection of ischemia and risk stratification in acute coronary syndrome
    • Apple, F.S. et al. Future biomarkers for detection of ischemia and risk stratification in acute coronary syndrome. Clin. Chem. 51, 810-824 (2005).
    • (2005) Clin. Chem. , vol.51 , pp. 810-824
    • Apple, F.S.1
  • 105
    • 0042367742 scopus 로고    scopus 로고
    • Preanalytic and analytic sources of variations in C-reactive protein measurement: Implications for cardiovascular disease risk assessment
    • Ledue, T.B. & Rifai, N. Preanalytic and analytic sources of variations in C-reactive protein measurement: implications for cardiovascular disease risk assessment. Clin. Chem. 49, 1258-1271 (2003).
    • (2003) Clin. Chem. , vol.49 , pp. 1258-1271
    • Ledue, T.B.1    Rifai, N.2
  • 106
    • 0028986689 scopus 로고
    • Biological variability in the concentration of serum lipids: Sources, meta-analysis, estimation, and minimization by relative range measurements
    • Cooper, G.R., Smith, S.J., Myers, G.L., Sampson, E.J. & Magid, E. Biological variability in the concentration of serum lipids: sources, meta-analysis, estimation, and minimization by relative range measurements. J. Int. Fed. Clin. Chem. 7, 23-28 (1995).
    • (1995) J. Int. Fed. Clin. Chem. , vol.7 , pp. 23-28
    • Cooper, G.R.1    Smith, S.J.2    Myers, G.L.3    Sampson, E.J.4    Magid, E.5
  • 107
    • 0037379907 scopus 로고    scopus 로고
    • Population distributions of C-reactive protein in apparently healthy men and women in the United States: Implication for clinical interpretation
    • Rifai, N. & Ridker, P.M. Population distributions of C-reactive protein in apparently healthy men and women in the United States: implication for clinical interpretation. Clin. Chem. 49, 666-669 (2003).
    • (2003) Clin. Chem. , vol.49 , pp. 666-669
    • Rifai, N.1    Ridker, P.M.2
  • 108
    • 0037232979 scopus 로고    scopus 로고
    • The STARD statement for reporting studies of diagnostic accuracy: Explanation and elaboration
    • Bossuyt, P.M. et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin. Chem. 49, 7-18 (2003).
    • (2003) Clin. Chem. , vol.49 , pp. 7-18
    • Bossuyt, P.M.1
  • 109
    • 0020031667 scopus 로고
    • On the use and computation of likelihood ratios in clinical chemistry
    • Albert, A. On the use and computation of likelihood ratios in clinical chemistry. Clin. Chem. 28, 1113-1119 (1982).
    • (1982) Clin. Chem. , vol.28 , pp. 1113-1119
    • Albert, A.1
  • 110
    • 0027457620 scopus 로고
    • Receiver-operating characteristic (ROC) plots: A fundamental evaluation tool in clinical medicine
    • Zweig, M.H. & Campbell, G. Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine. Clin. Chem. 39, 561-577 (1993).
    • (1993) Clin. Chem. , vol.39 , pp. 561-577
    • Zweig, M.H.1    Campbell, G.2
  • 112
    • 3042512345 scopus 로고    scopus 로고
    • ROC curves in clinical chemistry: Uses, misuses, and possible solutions
    • Obuchowski, N.A., Lieber, M.L. & Wians, F.H., Jr. ROC curves in clinical chemistry: uses, misuses, and possible solutions. Clin. Chem. 50, 1118-1125 (2004).
    • (2004) Clin. Chem. , vol.50 , pp. 1118-1125
    • Obuchowski, N.A.1    Lieber, M.L.2    Wians Jr., F.H.3
  • 113
    • 0018755784 scopus 로고
    • Application of Bayes's theorem to results of quantitative clinical chemical determinations
    • van der Helm, H.J. & Hische, E.A. Application of Bayes's theorem to results of quantitative clinical chemical determinations. Clin. Chem. 25, 985-988 (1979).
    • (1979) Clin. Chem. , vol.25 , pp. 985-988
    • Van Der Helm, H.J.1    Hische, E.A.2
  • 114
    • 0037006639 scopus 로고    scopus 로고
    • The architecture of diagnostic research
    • Sackett, D.L. & Haynes, R.B. The architecture of diagnostic research. Br. Med. J. 324, 539-541 (2002).
    • (2002) Br. Med. J. , vol.324 , pp. 539-541
    • Sackett, D.L.1    Haynes, R.B.2
  • 115
    • 33745954240 scopus 로고    scopus 로고
    • Diagnostics and biomarker development: Priming the pipeline
    • Phillips, K.A., Bebber, S.V. & Issa, A.M. Diagnostics and biomarker development: priming the pipeline. Nat. Rev. Drug Disc. 5, 463-469 (2006).
    • (2006) Nat. Rev. Drug Disc. , vol.5 , pp. 463-469
    • Phillips, K.A.1    Bebber, S.V.2    Issa, A.M.3
  • 116
    • 33747070880 scopus 로고    scopus 로고
    • CFR807
    • Code Federal Regulations, vol. 21 CFR807 http://frwebgate.access.gpo.gov/ cgi-bin/get-cfr.cgi?YEAR=current&TITLE=21&PART=807&SECTION= 81&SUBPART=&TYPE=TEXT
    • Code Federal Regulations , vol.21
  • 117
    • 33747060844 scopus 로고    scopus 로고
    • CFR814
    • Code Federal Regulations, vol. 21 CFR814 http://frwebgate.access.gpo.gov/ cgi-bin/get-cfr.cgi?YEAR=current&TITLE=21&PART=814&SECTION= 1&SUBPART=&TYPE=TEXT
    • Code Federal Regulations , vol.21
  • 119
    • 0142028108 scopus 로고    scopus 로고
    • The new European directive on in vitro diagnostics
    • Dati, F. The new European directive on in vitro diagnostics. Clin. Chem. Lab. Med. 41, 1289-1298 (2003).
    • (2003) Clin. Chem. Lab. Med. , vol.41 , pp. 1289-1298
    • Dati, F.1
  • 120
    • 0017221570 scopus 로고
    • Medical device amendments of 1976
    • Greenberg, R. Medical device amendments of 1976. Am. J. Hosp. Pharm. 33, 1308-1311 (1976).
    • (1976) Am. J. Hosp. Pharm. , vol.33 , pp. 1308-1311
    • Greenberg, R.1
  • 121
    • 33747059681 scopus 로고    scopus 로고
    • Regulations and interpretive guidelines for laboratories and laboratory services
    • USC1998. Centers for Medicare and Medicaid Services
    • Code Federal Register, vol. 21 USC1998. Regulations and interpretive guidelines for laboratories and laboratory services. Centers for Medicare and Medicaid Services. http://www.cms.hhs.gov/CLIA/downloads/apcindex.pdf
    • Code Federal Register , vol.21


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