메뉴 건너뛰기




Volumn 10, Issue 6, 2007, Pages 399-412

Design considerations for high throughput screening and in vitro diagnostic assays

Author keywords

Assay development; Disease prevalence; High throughput screening (HTS); In vitro diagnostics (IVD); Quality control (QC); Receiver operating characteristic curve (ROC); Shelf life stability; Six sigma; Statistical tools

Indexed keywords

REAGENT;

EID: 35448949421     PISSN: 13862073     EISSN: None     Source Type: Journal    
DOI: 10.2174/138620707781996475     Document Type: Review
Times cited : (26)

References (47)
  • 1
    • 26944475732 scopus 로고    scopus 로고
    • A guide to assay development
    • D&MD Report, 9114
    • Carter, J. M. "A guide to assay development", 2003, D&MD Report # 9114.
    • (2003)
    • Carter, J.M.1
  • 4
    • 35448997451 scopus 로고    scopus 로고
    • Manns, R. Microplate History, 1999, 2nd Edition, presented at MipTec-ICAR'99; available from the Internet at: http://www.microplate.org/history/det_hist.htm [accessed: 4-30-2007].
    • Manns, R. "Microplate History", 1999, 2nd Edition, presented at MipTec-ICAR'99; available from the Internet at: http://www.microplate.org/history/det_hist.htm [accessed: 4-30-2007].
  • 5
    • 35449002569 scopus 로고    scopus 로고
    • Bersch, C. Medical Laboratory Observer, 2006, September, 16-22 (http://www.mlo-online.com); [accessed: 4-30-2007].
    • Bersch, C. Medical Laboratory Observer, 2006, September, 16-22 (http://www.mlo-online.com); [accessed: 4-30-2007].
  • 7
    • 0025261742 scopus 로고
    • and
    • Mullis, K.B. Sci. Am., 1990, 262, 56 and 64.
    • (1990) Sci. Am , vol.262 , pp. 56-64
    • Mullis, K.B.1
  • 9
    • 23544467341 scopus 로고    scopus 로고
    • Human Genome Special Issue
    • "Human Genome Special Issue." Science, 2001, 291, 1145.
    • (2001) Science , vol.291 , pp. 1145
  • 10
    • 0035865210 scopus 로고    scopus 로고
    • The Human Genome
    • "The Human Genome." Nature, 2001, 409, 745.
    • (2001) Nature , vol.409 , pp. 745
  • 12
    • 35448980470 scopus 로고    scopus 로고
    • SBS Recommended Microplate Specifications Society of Biomolecular Sciences, 1999, available from the Internet at: www.sbsonline.org/msdc/pdf/text1999-05.pdf [accessed: 4-30-2007].
    • "SBS Recommended Microplate Specifications" Society of Biomolecular Sciences, 1999, available from the Internet at: www.sbsonline.org/msdc/pdf/text1999-05.pdf [accessed: 4-30-2007].
  • 13
    • 35448969862 scopus 로고    scopus 로고
    • Microplate Standards Working Group Society of Biomolecular Sciences, 2004, available from the Internet at: http://www.sbsonline.org/ msdc/approved.php [accessed: 4-30-2007].
    • "Microplate Standards Working Group" Society of Biomolecular Sciences, 2004, available from the Internet at: http://www.sbsonline.org/ msdc/approved.php [accessed: 4-30-2007].
  • 16
    • 35449000684 scopus 로고    scopus 로고
    • Engineering Statistics
    • accessed: 4-30-2007
    • "Engineering Statistics", NIST/SEMATECH e-Handbook of Statistical Methods, 2006, http://www.itl.nist.gov/div898/handbook/; [accessed: 4-30-2007].
    • (2006) NIST/SEMATECH e-Handbook of Statistical Methods
  • 19
    • 35448974218 scopus 로고    scopus 로고
    • Statistical Guidance on Reporting Results from Studies Evaluating Diagnostics Tests: Draft Guidance for Industry and FDA Reviewers, FDA web site (Rockville, MD), 2003, available from the Internet at: www.fda.gov/cdrh/osb/guidance/1428.html. [accessed 4-30-2007].
    • "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostics Tests: Draft Guidance for Industry and FDA Reviewers," FDA web site (Rockville, MD), 2003, available from the Internet at: www.fda.gov/cdrh/osb/guidance/1428.html. [accessed 4-30-2007].
  • 20
    • 35448938940 scopus 로고    scopus 로고
    • Medical Device Quality Systems Manual, U.S. Food and Drug Administration, 1997, available from the Internet at: http://www.fda.gov/cdrh/qsr/contnt.html [accessed 4-30-2007].
    • "Medical Device Quality Systems Manual", U.S. Food and Drug Administration, 1997, available from the Internet at: http://www.fda.gov/cdrh/qsr/contnt.html [accessed 4-30-2007].
  • 21
    • 35448987403 scopus 로고    scopus 로고
    • The Top 15 IVD Companies Report, Medical Products Outsourcing, 2006, available from the Internet at: http://www.mpomag.com/ articles/2006/06/top-ivd-companies-report [accessed: 4-30-2007].
    • "The Top 15 IVD Companies Report", Medical Products Outsourcing, 2006, available from the Internet at: http://www.mpomag.com/ articles/2006/06/top-ivd-companies-report [accessed: 4-30-2007].
  • 24
    • 35448963108 scopus 로고
    • The Cartoon Guide to Statistics, 1993
    • New York
    • Gonick, L. and Smith, W. The Cartoon Guide to Statistics, 1993, Harper-Resource: New York, 1993.
    • (1993) Harper-Resource
    • Gonick, L.1    Smith, W.2
  • 27
    • 35448999403 scopus 로고    scopus 로고
    • Bioanalytical Method Validation: Guidance for Industry, US Department of Health and Human Services, 2001, available from the Internet at: www.fda.gov/cder/Guidance/4252fnl.pdf [accessed: 4-30-2007].
    • "Bioanalytical Method Validation: Guidance for Industry," US Department of Health and Human Services, 2001, available from the Internet at: www.fda.gov/cder/Guidance/4252fnl.pdf [accessed: 4-30-2007].
  • 28
    • 35448990980 scopus 로고    scopus 로고
    • Assay Guidance Manual Version 4.1, Eli Lilly and Company and NIH Chemical Genomics Center, 2005, available from the Internet at: http://www.ncgc.nih.gov/guidance/manual_toc.html [accessed 4-30-2007].
    • "Assay Guidance Manual" Version 4.1, Eli Lilly and Company and NIH Chemical Genomics Center, 2005, available from the Internet at: http://www.ncgc.nih.gov/guidance/manual_toc.html [accessed 4-30-2007].
  • 41
    • 35448955405 scopus 로고    scopus 로고
    • Title: 21Code of Federal Regulations (21 CFR Part 11), Electronic Records, Electronic Signatures, 2003, available from the Internet at: http://www.fda.gov/ora/compliance_ref/part11/ [accessed: 4-30-2007].
    • "Title: 21Code of Federal Regulations (21 CFR Part 11), Electronic Records, Electronic Signatures," 2003, available from the Internet at: http://www.fda.gov/ora/compliance_ref/part11/ [accessed: 4-30-2007].


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.