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Table of Contents

November/December 2020; Volume 74,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. Aipperspach, Wolfgang

    1. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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. You have access
      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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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 74 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 6
November/December 2020
  • Table of Contents
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  • Complete Issue (PDF)
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  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
  • A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials
  • Low-Volume Aseptic Filling Using a Linear Peristaltic Pump
  • The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
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