Biology Reference
In-Depth Information
[2] US Department of Health and Human Services, Food and Drug Administration, Center for Devices and
Radiological Health, Office of In vitro Diagnostic Device Evaluation and Safety, Center for Biological Evaluation
and Research. 'Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In vitro Diagnostic Multivariate
Index Assays.' Retrieved from < http: // www.fda.gov / MedicalDevices / DeviceRegulationandGuidance / Guidance
Documents / ucm079148.htm > ; 2007 [accessed December 2012].
[3] Department of Health and Human Services, Food and Drug Administration. 'Drug Diagnostic Co-Development
Concept Paper.' Retrieved from < http: // www.fda.gov / downloads / Drugs / ScienceResearch / ResearchAreas /
Pharmacogenetics / UCM116689.pdf > ; 2005 [accessed December 2012].
[4] Lievre A, Bache JB, Le Corre D, Boige V, Landi B, Emile JF, et  al. KRAS mutation status is predictive of
response to cetuximab therapy in colorectal cancer. Cancer Res 2006;66:3992-5.
[5] Pollack A. Medical treatment, out of reach. The New York Times. Retrieved from < http: // www.nytimes.
com / 2011 / 02 / 10 / business / 10device.html?_r=0&adxnnl=1&pagewanted=all&adxnnlx=1353931534-ltQxlle3jOs-
nzMKz1Nu1fQ > ; 2011 [accessed December 2012].
[6] Spencer J, Walsh J. FDA rips Europe's system for medical device reviews. Star Tribune, Retrieved from:
< http: // www.startribune.com / business / 148313295.html?refer=y >; 2012 [accessed December 2012].
[7] Otsuji H, Minister of Health, Labour and Welfare. Ministerial Ordinance on Standards for Manufacturing Control
and Quality Control for Medical Devices and In vitro Diagnostic Reagents. Retrieved from: < http: // www.bsigroup.
jp / upload / PS-Assessment+Certiication / Documents / mdgmp_qms.pdf > ; 2004 [accessed December 2012].
[8] SFDA. Regulations for the Supervision and Administration of Medical Devices. Retrieved from < http: // www.
emergogroup.com / iles / china-medical-device-regulations.pdf > ; 2000 [accessed December 2012].
[9] European Commission, Enterprise and Industry. Directive 98 / 79 / EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic medical devices. Retrieved from: < http: // eur-lex.europa.eu /
LexUriServ / LexUriServ.do?uri=CELEX:31998L0079:en:NOT > ; 2008 [accessed December 2012].
[10] Center for Devices and Radiologic Health. The New 510(k) Paradigm, Alternative Approaches to Demonstrating
Substantial Equivalence in Premarket Notification: Final Guidance. Retrieved from: < http: // www.fda.gov /
MedicalDevices / DeviceRegulationandGuidance / GuidanceDocuments / ucm080187.htm > ; 1998 [accessed December
2012].
[11] US Food and Drug Administration. Device Approvals and Clearances. Retrieved from: < http: // www.fda.gov /
MedicalDevices / ProductsandMedicalProcedures / DeviceApprovalsandClearances / default.htm > ; 2012 [accessed
December 2012].
[12] Hastie T, Tibshirani R, Friedman JH. The elements of statistical learning. New York: Springer-Verlag; 2001.
[13] McLachlan GJ. Discriminant analysis and statistical pattern recognition. New York: Wiley; 1992.
[14] Ambroise C, McLachlan G. Selection bias in gene extraction on the basis of microarray gene expression data.
Proc Natl Acad Sci 2002;99:6562-6.
[15] Bousquet O, Elisseeff A. Stability and generalization. J Mach Learn Res 2002;2:499-526.
[16] Cawley GC, Talbot NC. On over-itting in model selection and subsequent selection bias in performance eval-
uation. J Mach Learn Res 2010;11:2079-107.
[17] Malone B. Big changes coming to molecular Dx reimbursement. Clin Lab News 2011;37(9) Retrieved from:
< http: // www.aacc.org / publications / cln / 2011 / September / Pages / MolecularDxReimbursement.aspx# > .
[18] Bellman RE. Dynamic programming. Princeton University Press; 1957. ISBN 978-0-691-07951-6.
[19] Bellman RE. Adaptive control processes: a guided tour. Princeton University Press; 1961.
[20] Donoho D. High-dimensional data analysis: the curses and blessings of dimensionality. Aide-Memoire of a
Lecture at AMS conference on Math Challenges of twenty-first Century. 2000.
[21] Kohavi R, John GH. Wrappers for feature subset selection. Artif Intell 1996;97:273-324.
[22] US Department of Health and Human Services, Food and Drug Administration, Center for Devices and
Radiological Health, Office of In vitro Diagnostic Device Evaluation and Safety, Center for Biological Evaluation
and Research. Guidance for Industry, Analytical Procedures and Methods Validation; Chemistry, Manufacturing,
and Controls Documentation Draft Guidance. Retrieved from: < http: // www.fda.gov / downloads / Drugs /
GuidanceComplianceRegulatoryInformation / Guidances / UCM122858.pdf > ; 2000 [accessed December 2012].
[23] Hartigan JA, Hartigan PM. The dip test of unimodality. Ann Statist 1985;13(1):70-84.
[24] Giroti RI, Verma S, Singh K, Malik R, Talwar I. A grey zone approach for evaluation of 15 short tandem repeat
loci in sibship analysis: a pilot study in Indian subjects. J Forensic Leg Med 2006;14(5):261-5.
[25] Coste J, Jourdain P, Pouchot J. A gray zone assigned to inconclusive results of quantitative diagnostic tests:
application to the use of brain natriuretic peptide for diagnosis of heart failure in acute dyspneic patients. Clin
Chem 2006;52(12):2229-35.
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