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Research ArticleResearch

Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys

Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao and Mary Kate Bielinski
PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 4-27; DOI: https://doi.org/10.5731/pdajpst.2024.012964
Steven A. Zdravkovic
1Baxter;
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Qiang Fu
2Hikma;
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Aaron Flick
3American Regent;
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Bhargava Jana
1Baxter;
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Elizabeth Looney
4Pfizer;
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Samuel Kikandi
5Sanofi; and
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Tim Verdonck
1Baxter;
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Lee Nagao
6Faegre, Drinker, Biddle and Reath
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Mary Kate Bielinski
6Faegre, Drinker, Biddle and Reath
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  • For correspondence: marykate.bielinski@faegredrinker.com
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References

  1. 1.↵
    U.S. Pharmacopeial Convention, <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. Pharmacopeial Forum 2013, 39(5), 270–290.
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  2. 2.↵
    Product Quality Research Institute. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. PQRI, 2006.
  3. 3.↵
    Product Quality Research Institute. Safety Thresholds and Best Practices for Extractables and Leachables in Parenteral Drug Products (Intravenous, Subcutaneous, and Intramuscular). PQRI, 2021.
  4. 4.↵
    International Organization for Standardization, ISO 10993-18 Biological Evaluation of Medical Devices—Part 18 Chemical Characterization of Medical Device Materials within a Risk Management Process. ISO: Geneva, 2020.
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    1. Heise T.,
    2. Sawyer A. Y.,
    3. Hirai T.,
    4. Schaible S.,
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    6. Wickramasekara S.
    Report on Investigation of ISO 10993–12 Extraction Conditions. Regul. Toxicol. Pharmacol. 2022, 131, 105164.
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  6. 6.↵
    1. Jenke D.
    Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes. PDA J. Pharm. Sci. Technol. 2023, 77 (4), 329–338.
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    1. Johnson C.,
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    9. Myatt G. J.
    Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments. PDA J. Pharm. Sci. Technol. 2024, 78 (3), 237–311.
    OpenUrlAbstract/FREE Full Text
  8. 8.↵
    1. Jenke D.,
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    Proposals for the Development, Composition, and Routine Use of System Suitability Standard Mixtures in Support of Chromatographic Screening for Organic Extractables and Leachables. https://doi.org/10.31003/USPNF_S203084_10101_01.
  9. 9.↵
    1. Zdravkovic S.
    A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials. PDA J. Pharm. Sci. Technol. 2021, 75 (6), 536–552.
    OpenUrlAbstract/FREE Full Text
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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 4-27; DOI: 10.5731/pdajpst.2024.012964

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Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 4-27; DOI: 10.5731/pdajpst.2024.012964
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Keywords

  • Extractable
  • Screening study
  • Uncertainty factor
  • Alignment
  • Inconsistent data

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