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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

July/August 2020; Volume 74,Issue 4
  • 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. Alvarez, Melissa

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

PDA Journal of Pharmaceutical Science and Technology: 74 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 4
July/August 2020
  • Table of Contents
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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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