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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

January/February 2016; Volume 70,Issue 1

Editorial

  • You have access
    War on Cancer Redux
    Govind Rao
    PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 1; DOI: https://doi.org/10.5731/pdajpst.2016.001094

Review

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    Integration of Regulatory Guidelines into Protein Drug Product Development
    Wei Wang
    PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 2-11; DOI: https://doi.org/10.5731/pdajpst.2015.005553

Research

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    Impact of Vial Capping on Residual Seal Force and Container Closure Integrity
    Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Robert Ovadia, Philippe Lam, Oliver Stauch, Martin Vogt, Holger Roehl, Joerg Huwyler, Silke Mohl and Alexander Streubel
    PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 12-29; DOI: https://doi.org/10.5731/pdajpst.2015.005876
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    Evaluation of Bacillus oleronius as a Biological Indicator for Terminal Sterilization of Large-Volume Parenterals
    Masamitsu Izumi, Masato Fujifuru, Aki Okada, Katsuya Takai, Kazuhiro Takahashi, Takeshi Udagawa, Makoto Miyake, Shintaro Naruyama, Hiroshi Tokuda, Goro Nishioka, Hikaru Yoden and Mitsuo Aoki
    PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 30-38; DOI: https://doi.org/10.5731/pdajpst.2015.005686
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    Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes
    Xujin Lu, David K. Lloyd and Steven E. Klohr
    PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 39-50; DOI: https://doi.org/10.5731/pdajpst.2015.006015
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    Characterization of Protein Aggregating Tungstates: Electrospray Mass Spectrometry Analysis of Extracts from Prefilled Syringes and from Tungsten Pins Used in the Manufacture of Syringes
    Michael Ronk, Hans Lee, Kiyoshi Fujimori, Ping Yeh and Yasser Nashed-Samuel
    PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 51-61; DOI: https://doi.org/10.5731/pdajpst.2015.005546

Technology/Application

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    Rapid Identification and Characterization of Formulated Protein Products by Raman Spectroscopy Coupled with Discriminant Analysis
    Xiaolin Cao, Dan Zhou, James A. Loussaert, David S. Meriage, Joseph D. Levine, John P. Gabrielson and Zai-Qing Wen
    PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 62-75; DOI: https://doi.org/10.5731/pdajpst.2015.005769

Case Studies

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    Particulate Study on NeoProfen, a Neonatal Injectable Product
    Aravind Krishna, Michael Rice, Tom Kester, Michael Waters and Terry Wilson
    PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 76-92; DOI: https://doi.org/10.5731/pdajpst.2015.005587
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 70 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 1
January/February 2016
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  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
  • A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials
  • Low-Volume Aseptic Filling Using a Linear Peristaltic Pump
  • The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
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