PDA Journal of Pharmaceutical Science and Technology: 74 (2)

March/April 2020; Volume 74,Issue 2

Guest Editorial

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PDA Responds to the Novel Coronavirus Situation
Richard M. Johnson

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 170; DOI: https://doi.org/10.5731/pdajpst.2019.001118

Research

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Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
Robert Ovadia, Philippe Lam, Vassia Tegoulia and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 171-184; DOI: https://doi.org/10.5731/pdajpst.2019.010363
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Investigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I Vials
Serena Panighello and Odra Pinato

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 185-200; DOI: https://doi.org/10.5731/pdajpst.2019.010066
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Bioprocess: Robustness with Respect to Mycoplasma Species
Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

Technology/Application

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Control Strategy Approach for a Well-Characterized Vaccine Drug Product
Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-Douglas

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
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Risk Assessment Approach to Microbiological Controls of Cell Therapies
Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546

Commentary

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Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
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Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
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Identification and Quantitation Classifications for Extractables and Leachables
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 275-285; DOI: https://doi.org/10.5731/pdajpst.2019.010538
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Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
Richard Rolke, Emma Ramnarine, Anders Vinther and Anil Sawant

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239

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Parenteral Drug Association, Inc.