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Research ArticlePDA Paper

Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products

Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037
Stan Bukofzer
Roles: Hospira, Inc (Chair)
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  • For correspondence: stan.bukofzer@hospira.com
John Ayres
Roles: Eli Lilly and Company
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Anna Chavez
Roles: Baxter
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Minerva Devera
Roles: Emergent
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Jahanvi Miller
Roles: Parenteral Drug Association (PDA)
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Douglas Ross
Roles: Pfizer
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John Shabushnig
Roles: Insight Pharma Consulting, LLC
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Susan Vargo
Roles: Amgen
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Harry Watson
Roles: CMQ/OE, Hospira, Inc
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Rick Watson
Roles: Merck
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PDA Journal of Pharmaceutical Science and Technology: 69 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 1
January/February 2015
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Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson, Rick Watson
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 123-139; DOI: 10.5731/pdajpst.2015.01037

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Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson, Rick Watson
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 123-139; DOI: 10.5731/pdajpst.2015.01037
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  • Article
    • Executive Summary
    • Introduction
    • Current Defined Rules
    • Evolving Stances and Drivers
    • Particle Matter Consideration
    • Particle Size
    • Pathophysiological Considerations and Clinical Implications
    • Risk Assessment
    • Quality Risk Management
    • Conclusion: Overall Medical Risk
    • References
  • Figures & Data
  • Info & Metrics
  • References
  • PDF

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Cited By...

  • Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
  • Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals
  • Achieving "Zero" Defects for Visible Particles in Injectables
  • Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial
  • A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products
  • Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
  • Filtration of Glass Delamination Particles with West Pharmaceutical Vial Adapters
  • Google Scholar

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