Table of Contents

November/December 2020; Volume 74,Issue 6

A

  1. Aipperspach, Wolfgang

    1. Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
      Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270

B

  1. BjÖrn, Hansmann

    1. Scalability of Sterilizing-Grade Filters in Different Filtration Modes
      Dippel Jannik, Handt Sebastian, Hansmann BjÖrn and Loewe Thomas
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 644-659; DOI: https://doi.org/10.5731/pdajpst.2019.011254

C

  1. Caraballo, Jose

    1. Lessons from a Pandemic: Maintaining Compliant GxP Surveillance Programs and Stable Pharmaceutical Supply
      Jose Caraballo and Fenton Fong
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 612-616; DOI: https://doi.org/10.5731/pdajpst.2020.012518

D

  1. Dias Loureiro, Rui Miguel

    1. Pharmaceutical Manufacturing in the EU and the EU–US Mutual Recognition Agreement
      LÍgia Maria Gaspar Ernesto and Rui Miguel Dias Loureiro
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 617-626; DOI: https://doi.org/10.5731/pdajpst.2020.011437

  2. Dong, Xia

    1. Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
      Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627

  3. Dreckmann, Tim

    1. Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
      Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270

E

  1. Ernst, Andreas

    1. Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
      Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270

F

  1. Fang, Liang

    1. Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
      Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627

  2. Fong, Fenton

    1. Lessons from a Pandemic: Maintaining Compliant GxP Surveillance Programs and Stable Pharmaceutical Supply
      Jose Caraballo and Fenton Fong
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 612-616; DOI: https://doi.org/10.5731/pdajpst.2020.012518

  3. Fujimori, Kiyoshi

    1. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
      Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379

G

  1. Gallegos, Alejandra

    1. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
      Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379

  2. Gaspar Ernesto, LÍgia Maria

    1. Pharmaceutical Manufacturing in the EU and the EU–US Mutual Recognition Agreement
      LÍgia Maria Gaspar Ernesto and Rui Miguel Dias Loureiro
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 617-626; DOI: https://doi.org/10.5731/pdajpst.2020.011437

H

  1. Huwyler, Joerg

    1. Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
      Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270

J

  1. Jannik, Dippel

    1. Scalability of Sterilizing-Grade Filters in Different Filtration Modes
      Dippel Jannik, Handt Sebastian, Hansmann BjÖrn and Loewe Thomas
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 644-659; DOI: https://doi.org/10.5731/pdajpst.2019.011254

  2. Joerg, Susanne

    1. Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
      Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini and Roman Mathaes
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 688-692; DOI: https://doi.org/10.5731/pdajpst.2020.011726

L

  1. Lee, Hans

    1. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
      Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379

  2. Li, Kim

    1. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
      Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379

  3. Liu, Jian

    1. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
      Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379

  4. Ludwig, Imke-Sonja

    1. Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
      Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270

  5. Luemkemann, Joerg

    1. Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
      Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270

  6. Luo, Yanxin

    1. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
      Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379

M

  1. Mahler, Hanns-Christian

    1. Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
      Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini and Roman Mathaes
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 688-692; DOI: https://doi.org/10.5731/pdajpst.2020.011726

  2. Mathaes, Roman

    1. Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
      Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini and Roman Mathaes
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 688-692; DOI: https://doi.org/10.5731/pdajpst.2020.011726

N

  1. Nashed-Samuel, Yasser

    1. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
      Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379

  2. Nonis, Lara

    1. Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
      Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini and Roman Mathaes
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 688-692; DOI: https://doi.org/10.5731/pdajpst.2020.011726

P

  1. Pfleghar, Kevin

    1. Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
      Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270

R

  1. Richard, Coralie ADÈle

    1. Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
      Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627

  2. Riesen, Franziska

    1. Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
      Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini and Roman Mathaes
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 688-692; DOI: https://doi.org/10.5731/pdajpst.2020.011726

  3. Roidl, Gabriele

    1. Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
      Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini and Roman Mathaes
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 688-692; DOI: https://doi.org/10.5731/pdajpst.2020.011726

  4. Ronk, Michael

    1. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
      Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379

S

  1. Sabini, Federico

    1. Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
      Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini and Roman Mathaes
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 688-692; DOI: https://doi.org/10.5731/pdajpst.2020.011726

  2. Sebastian, Handt

    1. Scalability of Sterilizing-Grade Filters in Different Filtration Modes
      Dippel Jannik, Handt Sebastian, Hansmann BjÖrn and Loewe Thomas
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 644-659; DOI: https://doi.org/10.5731/pdajpst.2019.011254

  3. Shi, Galen Huaiqiu

    1. Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
      Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627

  4. Shinkle, Sharon

    1. Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
      Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627

T

  1. Thomas, Justin C.

    1. Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
      Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627

  2. Thomas, Loewe

    1. Scalability of Sterilizing-Grade Filters in Different Filtration Modes
      Dippel Jannik, Handt Sebastian, Hansmann BjÖrn and Loewe Thomas
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 644-659; DOI: https://doi.org/10.5731/pdajpst.2019.011254

  3. TrÖndle, Julien

    1. Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
      Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270

V

  1. Victor, Michael C.

    1. Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
      Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627

  2. Vogt, Martin

    1. Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
      Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini and Roman Mathaes
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 688-692; DOI: https://doi.org/10.5731/pdajpst.2020.011726

W

  1. Wang, Tingting

    1. Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
      Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627

Z

  1. Zhao, Cathy

    1. Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
      Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
      PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627
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