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PDA Journal of Pharmaceutical Science and Technology

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Review ArticleReview

Evaluation of Different Estimation Methods for Accuracy and Precision in Biological Assay Validation

Binbing Yu and Harry Yang
PDA Journal of Pharmaceutical Science and Technology July 2017, 71 (4) 297-305; DOI: https://doi.org/10.5731/pdajpst.2016.007088
Binbing Yu
MEDIMMUNE LLC, GAITHERSBURG, MD
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  • For correspondence: yub@medimmune.com
Harry Yang
MEDIMMUNE LLC, GAITHERSBURG, MD
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  • Article
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Reference

  1. 1.↵
    USP. General Chapter 〈1033〉 Biological Assay Validation. The United States Pharmacopeia and The National Formulary; United States Pharmacopeial Convention: Rockville, MD, 2010.
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    1. Singer R.,
    2. Lansky D.,
    3. Hauck W.
    ; Bioassay Glossary. Presented at the Pharmacopeial Forum, 2006; pp 1359–1365.
  3. 3.↵
    FDA Draft Guidance for Industry Bioanalytical Method Validation (No. 78 FR 56718), 2013.
  4. 4.↵
    1. Kirkwood T. B.
    L. Geometric Means and Measures of Dispersion. Biometrics 1979, 35, 908–909.
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    Determination of Geometric Standard Deviation for Dissolution. Drug Dev. Ind. Pharm. 1991, 17(10), 1381–1387.
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    1. Bohidar N. R.
    A Rebuttal to the “Reply”. Drug Dev. Ind. Pharm. 1993, 19(3), 397–399.
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    1. Kirkwood T. B.
    L. Geometric Standard Deviation—Reply to Bohidar. Drug Dev. Ind. Pharm. 1993, 19(3), 395–396.
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  8. 8.↵
    1. Reed G. F.,
    2. Lynn F.,
    3. Meade B. D.
    Use of Coefficient of Variation in Assessing Variability of Quantitative Assays. Clinical and Diagnostic Laboratory Immunology 2002, 9(6), 1235–1239.
    OpenUrlAbstract/FREE Full Text
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    1. Tan C. Y.
    RSD and Other Variability Measures of the Lognormal Distribution. Pharmacopeial Forum 2005, 31(2) 653–655.
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  10. 10.↵
    1. Gates I. V.,
    2. Zhang Y.,
    3. Shambaugh C.,
    4. Bauman M. A.,
    5. Tan C.,
    6. Bodmer J. L.
    Quantitative Measurement of Varicella-Zoster Virus Infection by Semiautomated Flow Cytometry. Appl. Environ. Microbiol. 2009, 75(7), 2027–2036.
    OpenUrlAbstract/FREE Full Text
  11. 11.↵
    1. Attfield M. D.,
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    Exact Expressions for the Bias and Variance of Estimators of the Mean of a Lognormal Distribution. The American Industrial Hygiene Association Journal 1992, 53(7), 432–435.
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  12. 12.
    1. Steele J. M.
    The Cauchy-Schwarz Master Class: An Introduction to the Art of Mathematical Inequalities; MAA Problem Books Series; Cambridge University Press: Cambridge, U.K., 2004.
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 4
July/August 2017
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Evaluation of Different Estimation Methods for Accuracy and Precision in Biological Assay Validation
Binbing Yu, Harry Yang
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 297-305; DOI: 10.5731/pdajpst.2016.007088

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Evaluation of Different Estimation Methods for Accuracy and Precision in Biological Assay Validation
Binbing Yu, Harry Yang
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 297-305; DOI: 10.5731/pdajpst.2016.007088
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  • Article
    • Abstract
    • Introduction
    • Statistical Notes
    • Simulation
    • Estimation of Intermediate Precision
    • A Simple Example
    • Discussion
    • Conflict of Interest Declaration
    • Acknowledgements
    • Appendix 1. Estimates of Mean and Variance Estimates for the Three Proposed Methods
    • Appendix 2. Setting the Location and Scale Parameters ξ and ω for Simulation
    • Appendix 3. Asymptotic Distribution of Geometric Mean of Y1, Y2, … , Yn
    • Reference
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Keywords

  • Accuracy
  • Biological assay
  • Coefficient of variation (CV)
  • Precision
  • Relative bias
  • Relative potency
  • Relative standard deviation (RSD)

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