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PDA Journal of Pharmaceutical Science and Technology

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Review ArticleReview

Particulate Matter in Injectable Drug Products

Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 186-200; DOI: https://doi.org/10.5731/pdajpst.2013.00922
Stephen E. Langille
Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave, Bldg. 51, Rm. 4158 Silver Spring, MD 20993
Ph.D.
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  • For correspondence: Stephen.Langille@fda.hhs.gov
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Article Information

vol. 67 no. 3 186-200
DOI 
https://doi.org/10.5731/pdajpst.2013.00922
PubMed 
23752747

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online June 10, 2013.

Copyright & Usage 
© PDA, Inc. 2013

Author Information

  1. Stephen E. Langille, Ph.D.*
  1. Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave, Bldg. 51, Rm. 4158 Silver Spring, MD 20993
  1. ↵* Corresponding Author: Stephen E. Langille, Ph.D., Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave, Bldg. 51, Rm. 4158 Silver Spring, MD 20993. Telephone: 301-796-1557, e-mail: Stephen.Langille{at}fda.hhs.gov
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PDA Journal of Pharmaceutical Science and Technology: 67 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 3
May/June 2013
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Particulate Matter in Injectable Drug Products
Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 186-200; DOI: 10.5731/pdajpst.2013.00922

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Particulate Matter in Injectable Drug Products
Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 186-200; DOI: 10.5731/pdajpst.2013.00922
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  • Article
    • Abstract
    • Introduction
    • Classification and Sources of Particulate Matter
    • Clinical Effects of Injected Particulate Matter
    • Relevant Regulations and Standards
    • Continuing Efforts
    • Conclusion
    • Conflict of interest Declaration
    • Acknowledgements
    • References
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  • Best Practices to Quantify and Identify Particulate Matter on the Interior Surfaces of Single-Use Systems
  • Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
  • Tornado-inspired acoustic vortex tweezer for trapping and manipulating microbubbles
  • Visible Particulate Contamination Control for Injectable Products: A Life-Cycle Approach
  • Micro-Flow Imaging: Estimation of the Contribution of Key Factors to the Variability of Subvisible Particle Count Measurement by a Nested Statistical Analysis
  • Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals
  • Achieving "Zero" Defects for Visible Particles in Injectables
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Keywords

  • Injectable
  • Parenteral
  • Particulate matter
  • Pharmaceutical quality
  • Current good manufacturing practice (cGMP)

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