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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 Information

vol. 71 no. 4 297-305
DOI 
https://doi.org/10.5731/pdajpst.2016.007088
PubMed 
28416644

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online July 26, 2017.

Article Versions

  • previous version (April 17, 2017 - 05:46).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2017

Author Information

  1. Binbing Yu* and
  2. Harry Yang
  1. MEDIMMUNE LLC, GAITHERSBURG, MD
  1. ↵* Corresponding Author: MedImmune LLC, Gaithersburg, MD 20878, e-mail: yub{at}medimmune.com
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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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