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Research ArticleTechnology/Application

Implementation of Parallelism Testing for Four-Parameter Logistic Model in Bioassays

Harry Yang, Hyun Jun Kim, Lanju Zhang, Robert J. Strouse, Mark Schenerman and Xu-Rong Jiang
PDA Journal of Pharmaceutical Science and Technology May 2012, 66 (3) 262-269; DOI: https://doi.org/10.5731/pdajpst.2012.00867
Harry Yang
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  • For correspondence: YangH@MedImmune.com
Hyun Jun Kim
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Lanju Zhang
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Robert J. Strouse
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Mark Schenerman
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Xu-Rong Jiang
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Article Information

vol. 66 no. 3 262-269
DOI 
https://doi.org/10.5731/pdajpst.2012.00867
PubMed 
22634591

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 26, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. Harry Yang*,
  2. Hyun Jun Kim,
  3. Lanju Zhang,
  4. Robert J. Strouse,
  5. Mark Schenerman and
  6. Xu-Rong Jiang
  1. MedImmune, LLC, Gaithersburg, MD
  1. ↵* Correspondence author: YangH{at}MedImmune.com
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PDA Journal of Pharmaceutical Science and Technology: 66 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 3
May/June 2012
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Implementation of Parallelism Testing for Four-Parameter Logistic Model in Bioassays
Harry Yang, Hyun Jun Kim, Lanju Zhang, Robert J. Strouse, Mark Schenerman, Xu-Rong Jiang
PDA Journal of Pharmaceutical Science and Technology May 2012, 66 (3) 262-269; DOI: 10.5731/pdajpst.2012.00867

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Implementation of Parallelism Testing for Four-Parameter Logistic Model in Bioassays
Harry Yang, Hyun Jun Kim, Lanju Zhang, Robert J. Strouse, Mark Schenerman, Xu-Rong Jiang
PDA Journal of Pharmaceutical Science and Technology May 2012, 66 (3) 262-269; DOI: 10.5731/pdajpst.2012.00867
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  • Article
    • Abstract
    • Introduction
    • Four-Parameter Logistic Model
    • Intersection-Union Test
    • Determination of Equivalence Limits
    • Parallelism Analysis Template
    • Parallelism Testing Assessment with Known Inactive Product Variant
    • Conclusions
    • Conflict of Interest Declaration
    • Acknowledgments
    • References
  • Figures & Data
  • References
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  • PDF

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Cited By...

  • Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
  • A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation
  • Comment and Completion: Implementation of Parallelism Testing for Four-Parameter Logistic Model in Bioassays
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