Table of Contents

November/December 2013; Volume 67,Issue 6

A

  1. Adil, Nudrat

    1. 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

  2. Ahmad, Mansoor

    1. 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

B

  1. Buus, Peter

    1. 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
    2. 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
    3. 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

C

  1. Calnan, Nuala

    1. 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

  2. Chang, Stephen

    1. 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

D

  1. Damgaard, Rasmus

    1. 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
    2. 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
    3. 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

  2. Dietzsch, Christian

    1. 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

F

  1. Fujimori, Kiyoshi

    1. 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

G

  1. Gebala, Barbara

    1. 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

  2. Greene, Anne

    1. 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

  3. Guazzo, Dana Morton

    1. 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
    2. 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
    3. 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

H

  1. Herwig, Christoph

    1. 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

L

  1. Lee, Hans

    1. 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

  2. Li, Na

    1. 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

M

  1. Mulhall, Brian

    1. 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
    2. 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

N

  1. Nashed-Samuel, Yasser

    1. 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

O

  1. O'Donnell, Kevin

    1. 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

P

  1. Phillips, Joseph

    1. 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

R

  1. Rao, Govind

    1. 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

  2. Rasmussen, Mats

    1. 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
    2. 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
    3. 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

S

  1. Sandle, Tim

    1. 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

Y

  1. Yang, Harry

    1. 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

Z

  1. Zalai, Dénes

    1. 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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