Table of Contents

Research

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  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
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  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
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  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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  Excipient and Packaging Material Impact on Glass and Polymer-Based Prefilled Syringe Functionality

  PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 70-89; DOI: https://doi.org/10.5731/pdajpst.2022.012760