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PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
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Index by Author

November/December 2019; Volume 73,Issue 6
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

A

  1. Agalloco, James P.

    1. You have access
      The Bugs Don't Lie
      James P. Agalloco
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 615-621; DOI: https://doi.org/10.5731/pdajpst.2019.009894
  2. Amin, Magdy A.

    1. You have access
      A Validation Study of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Polyvalent Horse Snake Antivenom
      Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin and Hamdallah H. Zedan
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 562-571; DOI: https://doi.org/10.5731/pdajpst.2018.009522
  3. Anger, Sylvia

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  4. Asselta, Roger

    1. You have access
      Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
      Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 572-587; DOI: https://doi.org/10.5731/pdajpst.2018.009670

B

  1. Banton, Dwaine

    1. You have access
      The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
      Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg and John Schreffler
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 552-561; DOI: https://doi.org/10.5731/pdajpst.2019.010116
  2. Begat, Cecile

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  3. Biavati, Alberto

    1. You have access
      A Contribution to an Understanding of Complexing Agents and Salt Solutions Reaction Mechanism on Chemical Attack of Type I Molded Glass Containers
      Alberto Biavati, Giorgia Severi, Franco Bisceglie, Milena Marchegiani and Arianna Ferrarini
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 538-551; DOI: https://doi.org/10.5731/pdajpst.2018.009506
  4. Bisceglie, Franco

    1. You have access
      A Contribution to an Understanding of Complexing Agents and Salt Solutions Reaction Mechanism on Chemical Attack of Type I Molded Glass Containers
      Alberto Biavati, Giorgia Severi, Franco Bisceglie, Milena Marchegiani and Arianna Ferrarini
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 538-551; DOI: https://doi.org/10.5731/pdajpst.2018.009506
  5. Bulthuis, Ben

    1. You have access
      The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
      Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg and John Schreffler
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 552-561; DOI: https://doi.org/10.5731/pdajpst.2019.010116

C

  1. Crnko, Vincent

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645

D

  1. Deora, Aparna

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009
  2. Diab, Mohamed R.

    1. You have access
      A Validation Study of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Polyvalent Horse Snake Antivenom
      Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin and Hamdallah H. Zedan
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 562-571; DOI: https://doi.org/10.5731/pdajpst.2018.009522
  3. Du, Zhimei

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009

F

  1. Fantozzi, GianMaurizio

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  2. Farach, Wadi

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  3. Ferrarini, Arianna

    1. You have access
      A Contribution to an Understanding of Complexing Agents and Salt Solutions Reaction Mechanism on Chemical Attack of Type I Molded Glass Containers
      Alberto Biavati, Giorgia Severi, Franco Bisceglie, Milena Marchegiani and Arianna Ferrarini
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 538-551; DOI: https://doi.org/10.5731/pdajpst.2018.009506
  4. Fitzpatrick, Sean

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  5. Flores-Crespo, Carolina

    1. You have access
      Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
      Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 572-587; DOI: https://doi.org/10.5731/pdajpst.2018.009670
  6. Franck, Jason

    1. You have access
      Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
      Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 572-587; DOI: https://doi.org/10.5731/pdajpst.2018.009670

G

  1. Gallagher, Brian

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  2. Goldstein, Josh

    1. You have access
      The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
      Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg and John Schreffler
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 552-561; DOI: https://doi.org/10.5731/pdajpst.2019.010116

H

  1. Hauk, Armin

    1. You have access
      Using Extractables Data of Sterile Filter Components for Scaling Calculations
      Ina Pahl, Roberto Menzel, Armin Hauk and Thomas Loewe
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 523-537; DOI: https://doi.org/10.5731/pdajpst.2018.009647
  2. He, Luhong

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009
  3. Huelsmann, Stefan

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645

K

  1. Kinsey, Paul

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  2. Kulshrestha, Ankur

    1. You have access
      Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
      Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 572-587; DOI: https://doi.org/10.5731/pdajpst.2018.009670
  3. Kumar, Sampath R.

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009

L

  1. Langlade, Vincent

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  2. Lefevre, Ghislain

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  3. Legendre, Elise

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  4. Levy, Richard

    1. You have access
      Editor's Note
      Richard Levy
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 522; DOI: https://doi.org/10.5731/pdajpst.2019.001116
  5. Liu, Yan-Hui

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009
  6. Loewe, Thomas

    1. You have access
      Using Extractables Data of Sterile Filter Components for Scaling Calculations
      Ina Pahl, Roberto Menzel, Armin Hauk and Thomas Loewe
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 523-537; DOI: https://doi.org/10.5731/pdajpst.2018.009647

M

  1. Mantri, Rao V.

    1. You have access
      Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
      Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 572-587; DOI: https://doi.org/10.5731/pdajpst.2018.009670
  2. Marchegiani, Milena

    1. You have access
      A Contribution to an Understanding of Complexing Agents and Salt Solutions Reaction Mechanism on Chemical Attack of Type I Molded Glass Containers
      Alberto Biavati, Giorgia Severi, Franco Bisceglie, Milena Marchegiani and Arianna Ferrarini
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 538-551; DOI: https://doi.org/10.5731/pdajpst.2018.009506
  3. Marzilli, Lisa

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009
  4. McLean, Kevin

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  5. Menzel, Roberto

    1. You have access
      Using Extractables Data of Sterile Filter Components for Scaling Calculations
      Ina Pahl, Roberto Menzel, Armin Hauk and Thomas Loewe
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 523-537; DOI: https://doi.org/10.5731/pdajpst.2018.009647
  6. Miller, Jahanvi

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  7. Mueller, Hans-Martin

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009

N

  1. Nwosu, Charles

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009

O

  1. Oni, Yusuf

    1. You have access
      Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
      Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 572-587; DOI: https://doi.org/10.5731/pdajpst.2018.009670

P

  1. Pahl, Ina

    1. You have access
      Using Extractables Data of Sterile Filter Components for Scaling Calculations
      Ina Pahl, Roberto Menzel, Armin Hauk and Thomas Loewe
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 523-537; DOI: https://doi.org/10.5731/pdajpst.2018.009647
  2. Patel, Ravi

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  3. Perry, Anthony

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645

S

  1. Schrader, Matthew

    1. You have access
      Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
      Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 572-587; DOI: https://doi.org/10.5731/pdajpst.2018.009670
  2. Schreffler, John

    1. You have access
      The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
      Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg and John Schreffler
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 552-561; DOI: https://doi.org/10.5731/pdajpst.2019.010116
  3. Severi, Giorgia

    1. You have access
      A Contribution to an Understanding of Complexing Agents and Salt Solutions Reaction Mechanism on Chemical Attack of Type I Molded Glass Containers
      Alberto Biavati, Giorgia Severi, Franco Bisceglie, Milena Marchegiani and Arianna Ferrarini
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 538-551; DOI: https://doi.org/10.5731/pdajpst.2018.009506
  4. Sheraba, Norhan S.

    1. You have access
      A Validation Study of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Polyvalent Horse Snake Antivenom
      Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin and Hamdallah H. Zedan
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 562-571; DOI: https://doi.org/10.5731/pdajpst.2018.009522
  5. Song, Xu

    1. You have access
      Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
      Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 572-587; DOI: https://doi.org/10.5731/pdajpst.2018.009670
  6. Soukiassian, Herve

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  7. Stanton, Amy

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  8. Streich, Dorothee

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  9. Stults, John

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009

T

  1. Timmons, Christopher

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645

V

  1. Vacante, Dominick

    1. You have access
      The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
      Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg and John Schreffler
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 552-561; DOI: https://doi.org/10.5731/pdajpst.2019.010116
  2. Valliere-Douglass, John

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009
  3. Vaneylen, DAVID

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  4. van Hoose, Tony

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645

W

  1. Wang, Yan

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009
  2. Wildling, Linda

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  3. Windover, Mike

    1. You have access
      Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
      Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
  4. Wineburg, Michael

    1. You have access
      The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
      Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg and John Schreffler
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 552-561; DOI: https://doi.org/10.5731/pdajpst.2019.010116

Y

  1. Yaghmour, Sam

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009
  2. Yassin, Aymen S.

    1. You have access
      A Validation Study of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Polyvalent Horse Snake Antivenom
      Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin and Hamdallah H. Zedan
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 562-571; DOI: https://doi.org/10.5731/pdajpst.2018.009522

Z

  1. Zdravkovic, Steven A.

    1. You have access
      Comparison of the Extraction Properties of Binary Polysorbate 80/Water and Isopropanol/Water Solutions for Organic Substances Originating from a Parenteral Infusion Pump
      Steven A. Zdravkovic
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 588-614; DOI: https://doi.org/10.5731/pdajpst.2018.009753
  2. Zedan, Hamdallah H.

    1. You have access
      A Validation Study of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Polyvalent Horse Snake Antivenom
      Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin and Hamdallah H. Zedan
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 562-571; DOI: https://doi.org/10.5731/pdajpst.2018.009522
  3. Zhou, Yizhou

    1. You have access
      Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
      John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
      PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009
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PDA Journal of Pharmaceutical Science and Technology: 73 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
  • Table of Contents
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  • Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices
  • Low-Volume Aseptic Filling Using a Linear Peristaltic Pump
  • Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
  • Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes
  • Pharmaceutical Manufacturing in the EU and the EU–US Mutual Recognition Agreement
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