Leachables

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Correlating GC/MS Relative Response Factors to Analyte’s Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-Targeted Analysis (NTA). Concepts and Empirical Considerations
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 625-642; DOI: https://doi.org/10.5731/pdajpst.2023.012884
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Comparison of Binary Alcohol/Water Solvent Systems to Blood for Extractions of Blood-Contacting Medical Devices
Mark Anderson Jordi, Taryn Meade, Kevin Rowland, Chih-Hu Ho, Jordan Tocher and Weixi Liu

PDA Journal of Pharmaceutical Science and Technology September 2024, 78 (5) 560-571; DOI: https://doi.org/10.5731/pdajpst.2023.012892
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Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis
Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Martyn L. Chilton, Jessica Graham, Esther Johann, Candice Johnson, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Maureen T. Cruz and Lee Nagao

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 399-444; DOI: https://doi.org/10.5731/pdajpst.2022.012811
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In Silico Assessment of Biomolecule Reactivity with Leachables
Candice Johnson, Douglas Kiehl, Piet Christiaens, Ferran Sancho Jodar, Ruud Cuyvers, Arianna Bassan, Lisa Beilke, Joel P. Bercu, Thomas Costelloe, Kevin P. Cross, Andrew Feilden, Ron Filler, Maria Fátima Lucas, Melisa J. Masuda-Herrera, Mona Moghimi, Nick Morley, Diane Paskiet, Manuela Pavan, Julia Pletz, M. Vijayaraj Reddy, Christopher J. Waine and Glenn J. Myatt

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 214-236; DOI: https://doi.org/10.5731/pdajpst.2022.012818
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Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 358-366; DOI: https://doi.org/10.5731/pdajpst.2023.012868
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Challenges Associated with Biological Safety Assessments for Drug-Device Combination Products
Cheryl L. M. Stults, Diane Harper and Doris Zane

PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 100-124; DOI: https://doi.org/10.5731/pdajpst.2022.012822
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Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology July 2023, 77 (4) 329-338; DOI: https://doi.org/10.5731/pdajpst.2021.012671
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Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry
Lydia Breckenridge, Yusuf Oni, Christina Evans, Jason Franck, Sharla Wood, Meng Xu, Erinc Sahin and Brian Zacour

PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 197-210; DOI: https://doi.org/10.5731/pdajpst.2021.012655
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Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)
Melisa J. Masuda-Herrera, Joel P. Bercu, Thomas H. Broschard, Anders Burild, Catrin Hasselgren, Patricia Parris, Lucie C. Ford, Jessica Graham, Brad Stanard, Michele Comerford, Daniel Lettiere, Steffen Erler, Courtney M. Callis, Eric Morinello, Wolfgang Muster, Elizabeth A. Martin, Troy R. Griffin, Lee Nagao and Maureen Cruz

PDA Journal of Pharmaceutical Science and Technology September 2022, 76 (5) 369-383; DOI: https://doi.org/10.5731/pdajpst.2021.012693
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Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data When Screening for Extractables and Leachables by GC/MS?
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 236-247; DOI: https://doi.org/10.5731/pdajpst.2021.012673

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Parenteral Drug Association, Inc.