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Article CommentaryCommentary

A General Strategy for the Chemical Aspects of the Safety Assessment of Extractables and Leachables in Pharmaceutical Drug Products: The Chemical Assessment Triad

Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology March 2012, 66 (2) 168-183; DOI: https://doi.org/10.5731/pdajpst.2012.00855
Dennis Jenke
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References

  1. 1.↵
    Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, May, 1999.
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    Guideline on Plastic Immediate Packaging Materials. European Medicines Agency. CPMP/QWWP/4359/03. EMEA/CVMP/205/04. May 19, 2005.
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  3. 3.↵
    Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. QRI Leachables and Extractables Working Group, September 9, 2006, available at http://www.pqri.org/pdfs/LE-Recommendations-to-FDA-09-29-06.pdf.
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  4. 4.↵
    1. Martin J.,
    2. Fitzgerald R.,
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    4. Ding W.
    Recommendations for Testing and Evaluation of Extractables from Single-Use Process Equipment. Bio-Process Systems Alliance, 2010.
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  5. 5.↵
    1. Jenke D.
    Compatibility of Pharmaceutical Solutions and Contact Materials; Safety Considerations Associated with Extractables and Leachables; J. Wiley and Sons: New York, 2009.
    Google Scholar
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 66 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 2
March/April 2012
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A General Strategy for the Chemical Aspects of the Safety Assessment of Extractables and Leachables in Pharmaceutical Drug Products: The Chemical Assessment Triad
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Mar 2012, 66 (2) 168-183; DOI: 10.5731/pdajpst.2012.00855
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  • Article
    • Abstract
    • Introduction
    • Key Definitions
    • Genesis of the Triad
    • Further Development of the Triad
    • Tentative, Probable, and Confirmed Leachables
    • A High-Level Process Flow Diagram
    • Conflict of Interest Declaration
    • Acknowledgments
    • References
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  • Google Scholar

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  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review
  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
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A General Strategy for the Chemical Aspects of the Safety Assessment of Extractables and Leachables in Pharmaceutical Drug Products: The Chemical Assessment Triad
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Mar 2012, 66 (2) 168-183; DOI: 10.5731/pdajpst.2012.00855

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