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Research ArticleResearch

A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation

Steven Novick, Perceval Sondag, Tim Schofield and Kenneth Miller
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 249-263; DOI: https://doi.org/10.5731/pdajpst.2017.008094
Steven Novick
1MedImmune LLC, Gaithersburg, MD;
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  • For correspondence: novicks@medimmune.com
Perceval Sondag
2Arlenda Inc., Berwyn, PA; and
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Tim Schofield
3GlaxoSmithKline PLC, Rockville, MD
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Kenneth Miller
1MedImmune LLC, Gaithersburg, MD;
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Reference

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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 3
May/June 2018
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A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation
Steven Novick, Perceval Sondag, Tim Schofield, Kenneth Miller
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 249-263; DOI: 10.5731/pdajpst.2017.008094

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A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation
Steven Novick, Perceval Sondag, Tim Schofield, Kenneth Miller
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 249-263; DOI: 10.5731/pdajpst.2017.008094
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Calculation of Rp for Potency Assay
    • 3. Data Generation for Potency Assay
    • 4. Generating the “Missing” Rp Values
    • 5. Simulation
    • 6. A Motivating Example Data Set
    • 7. Discussion
    • Conflict of Interest Declaration
    • Acknowledgements
    • Reference
  • Figures & Data
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Keywords

  • Bioassay
  • Validation
  • Bayesian

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