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Research ArticleResearch

Micro-Flow Imaging: Estimation of the Contribution of Key Factors to the Variability of Subvisible Particle Count Measurement by a Nested Statistical Analysis

Kai Zhang, Thomas Wrzosek, Kashappa Goud Desai and Myrna Monck
PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 15-26; DOI: https://doi.org/10.5731/pdajpst.2018.009324
Kai Zhang
Departments of 1BioPharmaceutical Product Sciences and
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Thomas Wrzosek
2Statistics and Programming, GlaxoSmithKline Inc., 1250 S Collegeville Road, Collegeville, PA 19426
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Kashappa Goud Desai
Departments of 1BioPharmaceutical Product Sciences and
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Myrna Monck
Departments of 1BioPharmaceutical Product Sciences and
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  • For correspondence: Myrna.A.Monck@gsk.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 1
January/February 2020
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Micro-Flow Imaging: Estimation of the Contribution of Key Factors to the Variability of Subvisible Particle Count Measurement by a Nested Statistical Analysis
Kai Zhang, Thomas Wrzosek, Kashappa Goud Desai, Myrna Monck
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 15-26; DOI: 10.5731/pdajpst.2018.009324
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Keywords

  • Micro-flow imaging
  • Subvisible particles
  • Analytical variability
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  • statistical analysis
  • Assay precision

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Micro-Flow Imaging: Estimation of the Contribution of Key Factors to the Variability of Subvisible Particle Count Measurement by a Nested Statistical Analysis
Kai Zhang, Thomas Wrzosek, Kashappa Goud Desai, Myrna Monck
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 15-26; DOI: 10.5731/pdajpst.2018.009324

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