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PDA Journal of Pharmaceutical Science and Technology

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Index by Author

November/December 2013; Volume 67,Issue 6

Editorial

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    Mens Sana in Corpore Sano
    Govind Rao
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 568; DOI: https://doi.org/10.5731/pdajpst.2013.00956

Commentary

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    Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm
    Dénes Zalai, Christian Dietzsch and Christoph Herwig
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 569-580; DOI: https://doi.org/10.5731/pdajpst.2013.00943
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    Enabling ICH Q10 Implementation—Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9
    Nuala Calnan, Kevin O'Donnell and Anne Greene
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 581-600; DOI: https://doi.org/10.5731/pdajpst.2013.00940

Research

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    A Risk-based Approach to Setting Sterile Filtration Bioburden Limits
    Harry Yang, Na Li and Stephen Chang
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 601-609; DOI: https://doi.org/10.5731/pdajpst.2013.00942
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    Stability Studies of Two Different Polygelin (Haemaccel and Gelofusine) According to ICH Guidelines
    Mansoor Ahmad and Nudrat Adil
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 610-620; DOI: https://doi.org/10.5731/pdajpst.2013.00948

Case Studies

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    Comparison of Different Fungal Agar for the Environmental Monitoring of Pharmaceutical-Grade Cleanrooms
    Barbara Gebala and Tim Sandle
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 621-633; DOI: https://doi.org/10.5731/pdajpst.2013.00944

Technology/Application

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    High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 1. Method Development and Validation
    Rasmus Damgaard, Mats Rasmussen, Peter Buus, Brian Mulhall and Dana Morton Guazzo
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 634-651; DOI: https://doi.org/10.5731/pdajpst.2013.00945
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    High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 2. Method Performance as a Function of Heat Seal Defects, Product–Package Refrigeration, and Package Plastic Laminate Lot
    Mats Rasmussen, Rasmus Damgaard, Peter Buus, Brian Mulhall and Dana Morton Guazzo
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 652-663; DOI: https://doi.org/10.5731/pdajpst.2013.00946
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    High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 3. Chemical Stability and Visual Appearance of a Protein-Based Aqueous Solution for Injection as a Function of HVLD Exposure
    Mats Rasmussen, Rasmus Damgaard, Peter Buus and Dana Morton Guazzo
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 664-669; DOI: https://doi.org/10.5731/pdajpst.2013.00947
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    Development of an Inductively Coupled Plasma Mass Spectrometry Method for Quantification of Extracted Tungsten from Glass Prefilled Syringes Used as a Primary Packaging for Pharmaceutical and Therapeutic Protein Products
    Kiyoshi Fujimori, Hans Lee, Joseph Phillips and Yasser Nashed-Samuel
    PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 670-679; DOI: https://doi.org/10.5731/pdajpst.2013.00941
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 67 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 6
November/December 2013
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