Table of Contents

July/August 2020; Volume 74,Issue 4

A

  1. Alvarez, Melissa

    1. Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities
      Pao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. Arroyo
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611

  2. Arroyo, Adeyma Y.

    1. Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities
      Pao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. Arroyo
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611

B

  1. Bailey, Alison P.

    1. Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities
      Pao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. Arroyo
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611

  2. Bonnevay, Thierry

    1. Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices
      Marine Marius, Frédéric Vacher and Thierry Bonnevay
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 394-407; DOI: https://doi.org/10.5731/pdajpst.2019.010389

  3. Boone, Kenneth

    1. Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes
      Edward C. Tidswel and Kenneth Boone
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 408-422; DOI: https://doi.org/10.5731/pdajpst.2019.010975

  4. Bronzatti, Jeane Aparecida Gonzales

    1. Steam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization Cycles
      Paulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti and Kazuko Uchigawa Graziano
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 435-438; DOI: https://doi.org/10.5731/pdajpst.2019.009886

  5. Bruhin, Kimberly

    1. Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
      Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello Colao
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734

  6. Bucci, Anthony

    1. A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses
      Anthony Bucci, Le Ho, Lauren Orme and Qingyu Zeng
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 368-376; DOI: https://doi.org/10.5731/pdajpst.2019.010843

  7. Burdick, Richard K.

    1. The Goldilocks Challenge—Controlling Uncertainty When Setting Product Specifications
      Richard K. Burdick and Julia C. O'Neill
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 439-445; DOI: https://doi.org/10.5731/pdajpst.2019.010850

C

  1. Campanella, Anna

    1. Continuous and Effective Microbiological Air Monitoring in Critical Environments: A Comparison of Analytical Methodologies
      Gilberto Dalmaso, Anna Campanella and Paola Lazzeri
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 446-455; DOI: https://doi.org/10.5731/pdajpst.2019.010181

  2. Che, Pao Lin

    1. Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities
      Pao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. Arroyo
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611

  3. Chen, Shu

    1. A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages
      Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena Ingram
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173

  4. Colao, Marcello

    1. Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
      Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello Colao
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734

  5. Cundell, T.

    1. Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
      T. Cundell, D. Guilfoyle, T. R. Kreil and A. Sawant
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021

D

  1. Dalmaso, Gilberto

    1. Continuous and Effective Microbiological Air Monitoring in Critical Environments: A Comparison of Analytical Methodologies
      Gilberto Dalmaso, Anna Campanella and Paola Lazzeri
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 446-455; DOI: https://doi.org/10.5731/pdajpst.2019.010181

  2. de Souza, Rafael Queiroz

    1. Steam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization Cycles
      Paulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti and Kazuko Uchigawa Graziano
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 435-438; DOI: https://doi.org/10.5731/pdajpst.2019.009886

G

  1. Graziano, Kazuko Uchigawa

    1. Steam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization Cycles
      Paulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti and Kazuko Uchigawa Graziano
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 435-438; DOI: https://doi.org/10.5731/pdajpst.2019.009886

  2. Guilfoyle, D.

    1. Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
      T. Cundell, D. Guilfoyle, T. R. Kreil and A. Sawant
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021

H

  1. Ho, Le

    1. A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses
      Anthony Bucci, Le Ho, Lauren Orme and Qingyu Zeng
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 368-376; DOI: https://doi.org/10.5731/pdajpst.2019.010843

I

  1. Ingram, Marzena

    1. A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages
      Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena Ingram
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173

K

  1. Kreil, T. R.

    1. Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
      T. Cundell, D. Guilfoyle, T. R. Kreil and A. Sawant
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021

L

  1. Laranjeira, Paulo Roberto

    1. Steam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization Cycles
      Paulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti and Kazuko Uchigawa Graziano
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 435-438; DOI: https://doi.org/10.5731/pdajpst.2019.009886

  2. Lazzeri, Paola

    1. Continuous and Effective Microbiological Air Monitoring in Critical Environments: A Comparison of Analytical Methodologies
      Gilberto Dalmaso, Anna Campanella and Paola Lazzeri
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 446-455; DOI: https://doi.org/10.5731/pdajpst.2019.010181

  3. Levy, Richard

    1. July-August 2020 Issue
      Richard Levy
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 367; DOI: https://doi.org/10.5731/pdajpst.2019.001120

M

  1. Marius, Marine

    1. Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices
      Marine Marius, Frédéric Vacher and Thierry Bonnevay
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 394-407; DOI: https://doi.org/10.5731/pdajpst.2019.010389

O

  1. O'Neill, Julia C.

    1. The Goldilocks Challenge—Controlling Uncertainty When Setting Product Specifications
      Richard K. Burdick and Julia C. O'Neill
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 439-445; DOI: https://doi.org/10.5731/pdajpst.2019.010850

  2. Orme, Lauren

    1. A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses
      Anthony Bucci, Le Ho, Lauren Orme and Qingyu Zeng
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 368-376; DOI: https://doi.org/10.5731/pdajpst.2019.010843

P

  1. Pazhayattil, Ajay Babu

    1. A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages
      Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena Ingram
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173

R

  1. Ramnarine, Emma

    1. Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
      Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello Colao
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734

S

  1. Sawant, A.

    1. Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
      T. Cundell, D. Guilfoyle, T. R. Kreil and A. Sawant
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021

  2. Sayeed-Desta, Naheed

    1. A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages
      Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena Ingram
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173

T

  1. Tam, Chi Yan J.

    1. Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities
      Pao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. Arroyo
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611

  2. Tidswel, Edward C.

    1. Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes
      Edward C. Tidswel and Kenneth Boone
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 408-422; DOI: https://doi.org/10.5731/pdajpst.2019.010975

  3. Tovar, Christina

    1. Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
      Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello Colao
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734

V

  1. Vacher, Frédéric

    1. Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices
      Marine Marius, Frédéric Vacher and Thierry Bonnevay
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 394-407; DOI: https://doi.org/10.5731/pdajpst.2019.010389

  2. Vinther, Anders

    1. Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
      Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello Colao
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734

Z

  1. Zeng, Qingyu

    1. A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses
      Anthony Bucci, Le Ho, Lauren Orme and Qingyu Zeng
      PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 368-376; DOI: https://doi.org/10.5731/pdajpst.2019.010843
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