Index by Author

September/October 2020; Volume 74,Issue 5

A

  1. Akers, James

    1. Scientific Studies and Interpretation
      Edward C. Tidswell and James Akers
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 495-496; DOI: https://doi.org/10.5731/pdajpst.2020.012302

  2. Azarias, Marianne

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652

B

  1. Bolden, Jay

    1. Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
      Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187

  2. Booth, Crystal

    1. Investigating Aberrant Results in Microbiological Examination of Nonsterile Product Assays
      Crystal Booth
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 571-580; DOI: https://doi.org/10.5731/pdajpst.2019.010504

C

  1. Chung, Wen-Li

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652

D

  1. Dassu, Dawood

    1. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

  2. Dixit, Mandar

    1. Test Process and Results of Potential Masking of Sterilizing-Grade Filters
      Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph and Maik Jornitz
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 509-523; DOI: https://doi.org/10.5731/pdajpst.2019.011189
    2. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

F

  1. Ferrante, Stephanie

    1. Test Process and Results of Potential Masking of Sterilizing-Grade Filters
      Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph and Maik Jornitz
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 509-523; DOI: https://doi.org/10.5731/pdajpst.2019.011189
    2. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

G

  1. Gaerke, Jeff

    1. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

I

  1. Iyer, Kavita Ramalingam

    1. Risk-Based Approach for Analytical Comparability and Comparability Protocols
      Kavita Ramalingam Iyer and Isabelle Lequeux
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 563-570; DOI: https://doi.org/10.5731/pdajpst.2019.010439

J

  1. Jornitz, Maik

    1. Test Process and Results of Potential Masking of Sterilizing-Grade Filters
      Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph and Maik Jornitz
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 509-523; DOI: https://doi.org/10.5731/pdajpst.2019.011189

  2. Joseph, Brian

    1. Test Process and Results of Potential Masking of Sterilizing-Grade Filters
      Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph and Maik Jornitz
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 509-523; DOI: https://doi.org/10.5731/pdajpst.2019.011189
    2. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

K

  1. Kabakoff, Bruce

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652

  2. Knutsen, Chris

    1. Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
      Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187

  3. Kong, Connie

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652

L

  1. Lee, Kelvin H.

    1. NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies
      Jennifer L. Mantle and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 497-508; DOI: https://doi.org/10.5731/pdajpst.2019.011049

  2. Lequeux, Isabelle

    1. Risk-Based Approach for Analytical Comparability and Comparability Protocols
      Kavita Ramalingam Iyer and Isabelle Lequeux
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 563-570; DOI: https://doi.org/10.5731/pdajpst.2019.010439

  3. Levin, Jack

    1. Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
      Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187

M

  1. Mantle, Jennifer L.

    1. NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies
      Jennifer L. Mantle and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 497-508; DOI: https://doi.org/10.5731/pdajpst.2019.011049

  2. McBurnie, Leesa

    1. Test Process and Results of Potential Masking of Sterilizing-Grade Filters
      Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph and Maik Jornitz
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 509-523; DOI: https://doi.org/10.5731/pdajpst.2019.011189
    2. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

  3. Messick, Steven

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652

  4. Mills, Scott

    1. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

  5. Milne, Catherine

    1. Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
      Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187

  6. Morris, Tina

    1. Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
      Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187

  7. Mozier, Ned

    1. Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
      Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187

R

  1. Rahimi, Rod

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652

S

  1. Saggu, Miguel

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652

  2. Salaman-Byron, Angel L.

    1. Probable Scenarios of Process Contamination with Cutibacterium (Propionibacterium) acnes in Mammalian Cell Bioreactor
      Angel L. Salaman-Byron
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 592-601; DOI: https://doi.org/10.5731/pdajpst.2019.010710

  3. Spreitzer, Ingo

    1. Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
      Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187

  4. Stering, Magnus

    1. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

T

  1. Thome, Brian

    1. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

  2. Tidswell, Edward C.

    1. Scientific Studies and Interpretation
      Edward C. Tidswell and James Akers
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 495-496; DOI: https://doi.org/10.5731/pdajpst.2020.012302

  3. Tomlinson, Sean

    1. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

  4. Tschudi, Kate

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652

V

  1. von Wintzingerode, Friedrich

    1. Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
      Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187

W

  1. Weitzmann, Carl

    1. Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
      Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

  2. Woys, Ann

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652

Y

  1. Yin, Jian

    1. Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
      Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
      PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652
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