Table of Contents

March/April 2021; Volume 75,Issue 2

A

  1. Aaberg, Carsten

    1. ISO 9001:2015 Versus ICH Q10 — A Comparison
      Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau and Raman Srinivasan
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 188-206; DOI: https://doi.org/10.5731/pdajpst.2020.011692

B

  1. Bui, Uyentrang N.

    1. Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
      Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman and Martina Kron
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 173-187; DOI: https://doi.org/10.5731/pdajpst.2020.012096

C

  1. Cannon, James

    1. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
      Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419

  2. Caudill, Allison Alix

    1. Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
      Allison Alix Caudill, Ken Victor, Michael Timmins and James Veale
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 157-172; DOI: https://doi.org/10.5731/pdajpst.2020.011502

D

  1. Dahmen, Heribert

    1. ISO 9001:2015 Versus ICH Q10 — A Comparison
      Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau and Raman Srinivasan
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 188-206; DOI: https://doi.org/10.5731/pdajpst.2020.011692

  2. Dalmaso, Gilberto

    1. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
      Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419

  3. Davies, Cledwyn

    1. ISO 9001:2015 Versus ICH Q10 — A Comparison
      Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau and Raman Srinivasan
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 188-206; DOI: https://doi.org/10.5731/pdajpst.2020.011692

  4. Dingle, Mike

    1. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
      Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419

  5. Duan, Yuanyuan

    1. Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
      Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman and Martina Kron
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 173-187; DOI: https://doi.org/10.5731/pdajpst.2020.012096

F

  1. Forng, Ren-Yo

    1. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
      Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419

  2. Francis, James

    1. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
      Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419

H

  1. Hartman, Stephen E.

    1. Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
      Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman and Martina Kron
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 173-187; DOI: https://doi.org/10.5731/pdajpst.2020.012096

  2. Hooper, Scott

    1. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
      Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419

I

  1. Iwaniec, Aude

    1. Optimizing the Filtration of Liposomes Using Sterilizing-Grade Filters
      Kalliopi Zourna, Aude Iwaniec, Stephen Turner, Nigel B. Jackson and John H. Welsh
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 128-140; DOI: https://doi.org/10.5731/pdajpst.2020.011866

J

  1. Jackson, Nigel B.

    1. Optimizing the Filtration of Liposomes Using Sterilizing-Grade Filters
      Kalliopi Zourna, Aude Iwaniec, Stephen Turner, Nigel B. Jackson and John H. Welsh
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 128-140; DOI: https://doi.org/10.5731/pdajpst.2020.011866

K

  1. Kron, Martina

    1. Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
      Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman and Martina Kron
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 173-187; DOI: https://doi.org/10.5731/pdajpst.2020.012096

L

  1. Ljungqvist, Bengt

    1. People as a Contamination Source in Pharmaceutical Clean Rooms—Source Strengths and Calculated Concentrations of Airborne Contaminants
      Bengt Ljungqvist and Berit ReinmÜller
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 119-127; DOI: https://doi.org/10.5731/pdajpst.2020.012054

  2. Loeber, Diana

    1. Risk Mitigation of Drug Shortages—A New Concept for Vials Designed to Improve Fill and Finish Performance
      Holger Roehl, Stephanie Mangold, Florian Maurer and Diana Loeber
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 141-156; DOI: https://doi.org/10.5731/pdajpst.2020.011585

M

  1. Mangold, Stephanie

    1. Risk Mitigation of Drug Shortages—A New Concept for Vials Designed to Improve Fill and Finish Performance
      Holger Roehl, Stephanie Mangold, Florian Maurer and Diana Loeber
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 141-156; DOI: https://doi.org/10.5731/pdajpst.2020.011585

  2. Maurer, Florian

    1. Risk Mitigation of Drug Shortages—A New Concept for Vials Designed to Improve Fill and Finish Performance
      Holger Roehl, Stephanie Mangold, Florian Maurer and Diana Loeber
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 141-156; DOI: https://doi.org/10.5731/pdajpst.2020.011585

P

  1. Pflanzner, Thorsten

    1. Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
      Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman and Martina Kron
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 173-187; DOI: https://doi.org/10.5731/pdajpst.2020.012096

R

  1. ReinmÜller, Berit

    1. People as a Contamination Source in Pharmaceutical Clean Rooms—Source Strengths and Calculated Concentrations of Airborne Contaminants
      Bengt Ljungqvist and Berit ReinmÜller
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 119-127; DOI: https://doi.org/10.5731/pdajpst.2020.012054

  2. Roehl, Holger

    1. Risk Mitigation of Drug Shortages—A New Concept for Vials Designed to Improve Fill and Finish Performance
      Holger Roehl, Stephanie Mangold, Florian Maurer and Diana Loeber
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 141-156; DOI: https://doi.org/10.5731/pdajpst.2020.011585

  3. Russ, Mike

    1. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
      Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419

S

  1. Sandau, Pia Lise

    1. ISO 9001:2015 Versus ICH Q10 — A Comparison
      Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau and Raman Srinivasan
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 188-206; DOI: https://doi.org/10.5731/pdajpst.2020.011692

  2. Scott, Allison

    1. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
      Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419

  3. Srinivasan, Raman

    1. ISO 9001:2015 Versus ICH Q10 — A Comparison
      Carsten Aaberg, Heribert Dahmen, Cledwyn Davies, Pia Lise Sandau and Raman Srinivasan
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 188-206; DOI: https://doi.org/10.5731/pdajpst.2020.011692

T

  1. Timmins, Michael

    1. Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
      Allison Alix Caudill, Ken Victor, Michael Timmins and James Veale
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 157-172; DOI: https://doi.org/10.5731/pdajpst.2020.011502

  2. Turner, Stephen

    1. Optimizing the Filtration of Liposomes Using Sterilizing-Grade Filters
      Kalliopi Zourna, Aude Iwaniec, Stephen Turner, Nigel B. Jackson and John H. Welsh
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 128-140; DOI: https://doi.org/10.5731/pdajpst.2020.011866

V

  1. Veale, James

    1. Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
      Allison Alix Caudill, Ken Victor, Michael Timmins and James Veale
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 157-172; DOI: https://doi.org/10.5731/pdajpst.2020.011502

  2. Victor, Ken

    1. Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
      Allison Alix Caudill, Ken Victor, Michael Timmins and James Veale
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 157-172; DOI: https://doi.org/10.5731/pdajpst.2020.011502

  3. Villari, Philip

    1. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
      Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419

W

  1. Welsh, John H.

    1. Optimizing the Filtration of Liposomes Using Sterilizing-Grade Filters
      Kalliopi Zourna, Aude Iwaniec, Stephen Turner, Nigel B. Jackson and John H. Welsh
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 128-140; DOI: https://doi.org/10.5731/pdajpst.2020.011866

Z

  1. Zhang, Lanju

    1. Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
      Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman and Martina Kron
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 173-187; DOI: https://doi.org/10.5731/pdajpst.2020.012096

  2. Zourna, Kalliopi

    1. Optimizing the Filtration of Liposomes Using Sterilizing-Grade Filters
      Kalliopi Zourna, Aude Iwaniec, Stephen Turner, Nigel B. Jackson and John H. Welsh
      PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 128-140; DOI: https://doi.org/10.5731/pdajpst.2020.011866
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