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April 28, 2010 | History

Basic Method Validation 1 edition

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Basic Method Validation
2nd edition

Published June 30, 2003 by AACC Press .
Written in English.

About the Book

Basic Method Validation, Third Edition
Table of Contents

  1. Is quality still an issue for laboratory tests?
    -Myths of quality
  2. How do you manage quality?
    -The need for standard processes and standards of quality
  3. What is the purpose of a method validation study?
    -MV - The inner, hidden, deeper, secret meaning
  4. What are the regulatory requirements for method validation?
    -MV - The regulations, by Sharon S. Ehrmeyer, PhD
  5. How is a method selected?
    -MV - Selecting a method to validate
  6. What experiments are necessary to validate method performance?
    -MV - The experimental plan
  7. How are the experimental data analyzed?
    -MV - The data analysis tool kit
  8. How are the statistics calculated?
    -MV - The statistical calculations
  9. How is the reportable range of a method determined?
    -MV - The linearity or reportable range experiment
    -Problem set - Cholesterol method validation data
  10. How is the imprecision of a method determined?
    -MV - The replication experiment
    -Problem set - Cholesterol method validation data
  11. How is the inaccuracy (bias) of a method determined?
    -MV - The comparison of methods experiment
    -Problem set - Cholesterol method validation data
  12. How do you use statistics to estimate analytical errors?
    -Statistical sense, sensitivity, and significance
  13. How do you test for specific sources of inaccuracy?
    -MV - The interference and recovery experiments
    -Problem set - Cholesterol method validation data
  14. What is the lowest test value that is reliable?
    -MV - The detection limit experiment
    Problem set - Cholesterol method validation data
  15. How is a reference interval verified?
    -MV - Reference interval transference
  16. How do you judge the performance of a method?
    -MV - The decision on method performance
  17. What's a practical procedure for validating a method?
    -MV - The real world applications
    -MV - The worksheets
  18. How do you use statistics in the real world?
    -Points of care in using statistics in method comparison studies
  19. How can a manufacturer's claims be verified?
    -Verifying a claim for precision and trueness
  20. How can claims be evaluated on the Sigma-scale?
    Translating performance claims into Sigma-metrics
  21. What impact will ISO have on analytical quality?
    -Quality Concepts: is it better to be uncertain or in error?
  22. Self-Assessment Answers
    -Cholesterol Problem Set answers

Appendix 1: CLIA Analytical Quality Requirements

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History Created December 11, 2009 · 2 revisions Download catalog record: RDF / JSON

April 28, 2010 Edited by Open Library Bot Linked existing covers to the work.
December 11, 2009 Created by WorkBot add works page