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Research ArticleResearch

A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error

Harry Yang and Jianchun Zhang
PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 725-735; DOI: https://doi.org/10.5731/pdajpst.2015.01081
Harry Yang
MedImmune, LLC
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  • For correspondence: yangh@medimmune.com
Jianchun Zhang
MedImmune, LLC
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PDA Journal of Pharmaceutical Science and Technology: 69 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 6
November/December 2015
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A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error
Harry Yang, Jianchun Zhang
PDA Journal of Pharmaceutical Science and Technology Nov 2015, 69 (6) 725-735; DOI: 10.5731/pdajpst.2015.01081

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A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error
Harry Yang, Jianchun Zhang
PDA Journal of Pharmaceutical Science and Technology Nov 2015, 69 (6) 725-735; DOI: 10.5731/pdajpst.2015.01081
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Method Validation Based On Total Error
    • 3. Current Methods
    • 4. Alternative Approach
    • 4.1. Generalized Pivotal Quantity (GPQ)
    • 5. Simulation
    • 6. Conclusion
    • Acknowledgment
    • References
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Keywords

  • Consumer's risk
  • generalized pivotal quantity
  • Method validation
  • Tolerance interval
  • Total error
  • Type I error

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