Table of Contents

November/December 2019; Volume 73,Issue 6

A

  1. Agalloco, James P.

    1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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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