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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
MD
Roles: Hospira, Inc (Chair)
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  • For correspondence: stan.bukofzer@hospira.com
John Ayres
MD
Roles: Eli Lilly and Company
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Anna Chavez
MD
Roles: Baxter
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Minerva Devera
DBA, QSM
Roles: Emergent
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Jahanvi Miller
MBA
Roles: Parenteral Drug Association (PDA)
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Douglas Ross
MD
Roles: Pfizer
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John Shabushnig
PhD
Roles: Insight Pharma Consulting, LLC
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Susan Vargo
MS, PhD
Roles: Amgen
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Harry Watson
MTSC
Roles: CMQ/OE, Hospira, Inc
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Rick Watson
Roles: Merck
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  • Article
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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
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  • A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products
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