Chapter 16. Validation of New Bioanalytical Methods

  1. Susan R. Mikkelsen1,
  2. Eduardo Cortón2

Published Online: 26 FEB 2004

DOI: 10.1002/0471623628.ch16

Book Title

Bioanalytical Chemistry

Bioanalytical Chemistry

Additional Information

How to Cite

Mikkelsen, S. R. and Cortón, E. (2004) Validation of New Bioanalytical Methods, in Bioanalytical Chemistry, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/0471623628.ch16

Author Information

  1. 1

    University of Waterloo, Ontario, Canada

  2. 2

    University of Buenos Aires, Argentina

Publication History

  1. Published Online: 26 FEB 2004
  2. Published Print: 20 FEB 2004

ISBN Information

Print ISBN: 9780471544470

Online ISBN: 9780471623625

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CHAPTER TOOLS

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Keywords:

  • validation;
  • statistics;
  • precision;
  • accuracy;
  • calibration;
  • detection/quantitation limits;
  • linear regression;
  • precision profile;
  • quantitative analysis;
  • qualitative analysis;
  • matrix effects;
  • recovery;
  • parallelism;
  • interferences;
  • cutoff values

Summary

Principles and applications of the validation of new bioanalytical methods, including precision and accuracy, mean and variance, RSD and other precision estimators, distribution of errors and confidence limits, linear regression and calibration, precision profiles, limit of quantitiation and detection, linearizing sigmoid curves (four-parameter Log–Logit model), effective dose method, estimation of accuracy, standardization, matrix effects, recovery, parallelism, interferences, qualitative (screening) assays and their figures of merit, examples of validation procedures.

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