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PDA Journal of Pharmaceutical Science and Technology

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Leachables

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    Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
    Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
    PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379
  • You have access
    The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the AET Adjusted for Response Factor Variation
    Dennis Jenke and Ted Heise
    PDA Journal of Pharmaceutical Science and Technology November 2020, pdajpst.2020.012013; DOI: https://doi.org/10.5731/pdajpst.2020.012013
  • You have access
    An Analytical Strategy Based on Multiple Complementary and Orthogonal Chromatographic and Detection Methods (Multidetector Approach) to Effectively Manage the Analytical Evaluation Threshold (AET)
    Mark A Jordi and Ted Heise
    PDA Journal of Pharmaceutical Science and Technology November 2020, pdajpst.2020.012047; DOI: https://doi.org/10.5731/pdajpst.2020.012047
  • You have access
    Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: An Updated Literature Review
    Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 324-347; DOI: https://doi.org/10.5731/pdajpst.2019.010033
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    Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables
    Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: https://doi.org/10.5731/pdajpst.2019.010520
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    Identification and Quantitation Classifications for Extractables and Leachables
    Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 275-285; DOI: https://doi.org/10.5731/pdajpst.2019.010538
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    Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation
    Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 108-133; DOI: https://doi.org/10.5731/pdajpst.2018.009779
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    Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3—Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices
    Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 134-146; DOI: https://doi.org/10.5731/pdajpst.2018.009787
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    Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
    Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 90-107; DOI: https://doi.org/10.5731/pdajpst.2018.009761
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    Comparative Leachable Study of Glass Vials to Demonstrate the Impact of Low Fill Volume
    Bernhard Hladik, Florence Buscke, Robert Frost and Uwe Rothhaar
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 345-355; DOI: https://doi.org/10.5731/pdajpst.2018.009472

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