Table of Contents

January/February 2024; Volume 78,Issue 1

  1. Aluri, Rajendra

    1. Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental Results
      Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri and Valer Toşa
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 3-32; DOI: https://doi.org/10.5731/pdajpst.2022.012816
    2. Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 2: Conservative Diffusion and Partition Coefficient Determinations
      Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri and Valer Toşa
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 33-44; DOI: https://doi.org/10.5731/pdajpst.2022.012817

  2. Barge, Vishal

    1. Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental Results
      Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri and Valer Toşa
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 3-32; DOI: https://doi.org/10.5731/pdajpst.2022.012816
    2. Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 2: Conservative Diffusion and Partition Coefficient Determinations
      Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri and Valer Toşa
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 33-44; DOI: https://doi.org/10.5731/pdajpst.2022.012817

  3. Cantin, Veronique

    1. Best Practices to Quantify and Identify Particulate Matter on the Interior Surfaces of Single-Use Systems
      Klaus Wormuth, Fanny Gaston, Melanie Gauthier, Veronique Cantin and Nelly Montenay
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 90-99; DOI: https://doi.org/10.5731/pdajpst.2022.012755

  4. Conners, James

    1. Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and Other Drug-–Device Combination Products
      Cheryl L. M. Stults, Christine L. Lanning, Lee M. Nagao and James Conners
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 125-139; DOI: https://doi.org/10.5731/pdajpst.2023.012852

  5. Fang, Liang

    1. Excipient and Packaging Material Impact on Glass and Polymer-Based Prefilled Syringe Functionality
      Liang Fang and Marissa Rase
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 70-89; DOI: https://doi.org/10.5731/pdajpst.2022.012760

  6. Gaston, Fanny

    1. Best Practices to Quantify and Identify Particulate Matter on the Interior Surfaces of Single-Use Systems
      Klaus Wormuth, Fanny Gaston, Melanie Gauthier, Veronique Cantin and Nelly Montenay
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 90-99; DOI: https://doi.org/10.5731/pdajpst.2022.012755

  7. Gauthier, Melanie

    1. Best Practices to Quantify and Identify Particulate Matter on the Interior Surfaces of Single-Use Systems
      Klaus Wormuth, Fanny Gaston, Melanie Gauthier, Veronique Cantin and Nelly Montenay
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 90-99; DOI: https://doi.org/10.5731/pdajpst.2022.012755

  8. Harper, Diane

    1. 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

  9. Herburger, Matthias

    1. Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental Results
      Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri and Valer Toşa
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 3-32; DOI: https://doi.org/10.5731/pdajpst.2022.012816
    2. Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 2: Conservative Diffusion and Partition Coefficient Determinations
      Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri and Valer Toşa
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 33-44; DOI: https://doi.org/10.5731/pdajpst.2022.012817

  10. Kitamura, Riho

    1. Creating an Assessment Indicator of Quality Culture Development in the Generic Pharmaceutical Industry in Japan
      Shiho Takahashi, Tetsuhito Takarada, Riho Kitamura, Mayumi Shikano and Shingou Sakurai
      PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 45-69; DOI: https://doi.org/10.5731/pdajpst.2022.012824
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