Table of Contents
July/August 2020; Volume 74,Issue 4
A
Alvarez, Melissa
- You have accessDetermining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct FacilitiesPao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. ArroyoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611
Arroyo, Adeyma Y.
- You have accessDetermining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct FacilitiesPao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. ArroyoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611
B
Bailey, Alison P.
- You have accessDetermining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct FacilitiesPao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. ArroyoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611
Bonnevay, Thierry
- You have accessComparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex MatricesMarine Marius, Frédéric Vacher and Thierry BonnevayPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 394-407; DOI: https://doi.org/10.5731/pdajpst.2019.010389
Boone, Kenneth
- You have accessEnvironmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnesEdward C. Tidswel and Kenneth BoonePDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 408-422; DOI: https://doi.org/10.5731/pdajpst.2019.010975
Bronzatti, Jeane Aparecida Gonzales
- You have accessSteam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization CyclesPaulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti and Kazuko Uchigawa GrazianoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 435-438; DOI: https://doi.org/10.5731/pdajpst.2019.009886
Bruhin, Kimberly
- You have accessIndustry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based ApproachesEmma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello ColaoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734
Bucci, Anthony
- You have accessA Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up AnalysesAnthony Bucci, Le Ho, Lauren Orme and Qingyu ZengPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 368-376; DOI: https://doi.org/10.5731/pdajpst.2019.010843
Burdick, Richard K.
- You have accessThe Goldilocks Challenge—Controlling Uncertainty When Setting Product SpecificationsRichard K. Burdick and Julia C. O'NeillPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 439-445; DOI: https://doi.org/10.5731/pdajpst.2019.010850
C
Campanella, Anna
- You have accessContinuous and Effective Microbiological Air Monitoring in Critical Environments: A Comparison of Analytical MethodologiesGilberto Dalmaso, Anna Campanella and Paola LazzeriPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 446-455; DOI: https://doi.org/10.5731/pdajpst.2019.010181
Che, Pao Lin
- You have accessDetermining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct FacilitiesPao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. ArroyoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611
Chen, Shu
- You have accessA Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle StagesAjay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena IngramPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173
Colao, Marcello
- You have accessIndustry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based ApproachesEmma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello ColaoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734
Cundell, T.
- You have accessControls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 PandemicT. Cundell, D. Guilfoyle, T. R. Kreil and A. SawantPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021
D
Dalmaso, Gilberto
- You have accessContinuous and Effective Microbiological Air Monitoring in Critical Environments: A Comparison of Analytical MethodologiesGilberto Dalmaso, Anna Campanella and Paola LazzeriPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 446-455; DOI: https://doi.org/10.5731/pdajpst.2019.010181
de Souza, Rafael Queiroz
- You have accessSteam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization CyclesPaulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti and Kazuko Uchigawa GrazianoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 435-438; DOI: https://doi.org/10.5731/pdajpst.2019.009886
G
Graziano, Kazuko Uchigawa
- You have accessSteam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization CyclesPaulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti and Kazuko Uchigawa GrazianoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 435-438; DOI: https://doi.org/10.5731/pdajpst.2019.009886
Guilfoyle, D.
- You have accessControls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 PandemicT. Cundell, D. Guilfoyle, T. R. Kreil and A. SawantPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021
H
Ho, Le
- You have accessA Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up AnalysesAnthony Bucci, Le Ho, Lauren Orme and Qingyu ZengPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 368-376; DOI: https://doi.org/10.5731/pdajpst.2019.010843
I
Ingram, Marzena
- You have accessA Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle StagesAjay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena IngramPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173
K
Kreil, T. R.
- You have accessControls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 PandemicT. Cundell, D. Guilfoyle, T. R. Kreil and A. SawantPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021
L
Laranjeira, Paulo Roberto
- You have accessSteam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization CyclesPaulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti and Kazuko Uchigawa GrazianoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 435-438; DOI: https://doi.org/10.5731/pdajpst.2019.009886
Lazzeri, Paola
- You have accessContinuous and Effective Microbiological Air Monitoring in Critical Environments: A Comparison of Analytical MethodologiesGilberto Dalmaso, Anna Campanella and Paola LazzeriPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 446-455; DOI: https://doi.org/10.5731/pdajpst.2019.010181
Levy, Richard
- You have accessJuly-August 2020 IssueRichard LevyPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 367; DOI: https://doi.org/10.5731/pdajpst.2019.001120
M
Marius, Marine
- You have accessComparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex MatricesMarine Marius, Frédéric Vacher and Thierry BonnevayPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 394-407; DOI: https://doi.org/10.5731/pdajpst.2019.010389
O
O'Neill, Julia C.
- You have accessThe Goldilocks Challenge—Controlling Uncertainty When Setting Product SpecificationsRichard K. Burdick and Julia C. O'NeillPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 439-445; DOI: https://doi.org/10.5731/pdajpst.2019.010850
Orme, Lauren
- You have accessA Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up AnalysesAnthony Bucci, Le Ho, Lauren Orme and Qingyu ZengPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 368-376; DOI: https://doi.org/10.5731/pdajpst.2019.010843
P
Pazhayattil, Ajay Babu
- You have accessA Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle StagesAjay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena IngramPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173
R
Ramnarine, Emma
- You have accessIndustry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based ApproachesEmma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello ColaoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734
S
Sawant, A.
- You have accessControls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 PandemicT. Cundell, D. Guilfoyle, T. R. Kreil and A. SawantPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021
Sayeed-Desta, Naheed
- You have accessA Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle StagesAjay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena IngramPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173
T
Tam, Chi Yan J.
- You have accessDetermining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct FacilitiesPao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. ArroyoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611
Tidswel, Edward C.
- You have accessEnvironmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnesEdward C. Tidswel and Kenneth BoonePDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 408-422; DOI: https://doi.org/10.5731/pdajpst.2019.010975
Tovar, Christina
- You have accessIndustry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based ApproachesEmma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello ColaoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734
V
Vacher, Frédéric
- You have accessComparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex MatricesMarine Marius, Frédéric Vacher and Thierry BonnevayPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 394-407; DOI: https://doi.org/10.5731/pdajpst.2019.010389
Vinther, Anders
- You have accessIndustry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based ApproachesEmma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello ColaoPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734
Z
Zeng, Qingyu
- You have accessA Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up AnalysesAnthony Bucci, Le Ho, Lauren Orme and Qingyu ZengPDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 368-376; DOI: https://doi.org/10.5731/pdajpst.2019.010843
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 4
July/August 2020
