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Article CommentaryCommentary

Conducting Clinical Risk Assessments for Visible Particulate Matter in Parenteral Preparations

John D. Ayres
PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 626-639; DOI: https://doi.org/10.5731/pdajpst.2018.008615
John D. Ayres
Pharma Safety Solutions, LLC, IN, USA.
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Article Information

vol. 72 no. 6 626-639
DOI 
https://doi.org/10.5731/pdajpst.2018.008615
PubMed 
30158238

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 4, 2018.

Article Versions

  • previous version (August 29, 2018 - 07:12).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. John D. Ayres*
  1. Pharma Safety Solutions, LLC, IN, USA.
  1. ↵*Corresponding Author: Pharma Safety Solutions, LLC, 16333 Valhalla Drive, Noblesville, IN 46060, USA; e-mail: jayres1790{at}gmail.com
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PDA Journal of Pharmaceutical Science and Technology: 72 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
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Conducting Clinical Risk Assessments for Visible Particulate Matter in Parenteral Preparations
John D. Ayres
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 626-639; DOI: 10.5731/pdajpst.2018.008615

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Conducting Clinical Risk Assessments for Visible Particulate Matter in Parenteral Preparations
John D. Ayres
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 626-639; DOI: 10.5731/pdajpst.2018.008615
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Jump to section

  • Article
    • Abstract
    • Introduction
    • Background
    • Characterizing the Clinical Risk
    • Assessing the Clinical Risk
    • Sources of Particles
    • Particle-Related Attributes
    • Patient-Related Factors
    • Conducting the Assessment
    • Differentiating Clinical Risk Assessment and Product Risk Acceptance for Visible Particles
    • Subvisible Particles
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgments
    • Footnotes
    • Reference
  • References
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  • Comparing visual inspection methods for parenteral products in hospital pharmacy: between reliability, cost, and operator formation considerations
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  • Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
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Keywords

  • Particles
  • Injectables
  • Clinical Risk Assessment
  • visual inspection
  • Patient Safety

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