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PDA Journal of Pharmaceutical Science and Technology

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Accepted Articles

Each month, PDA Journal of Pharmaceutical Science and Technology publishes articles accepted for publication in advance to final issue designation, with the permission of the authors. Accepted Articles are the unedited, unformatted manuscripts that are accepted by the Editor-in-Chief following a successful peer-review. These drafts will be removed from Accepted Articles when the final and typeset version of record are published in an issue of the journal. 
 

To see an article, click its [PDF] link. To review many abstracts, check the boxes to the left of the titles you want, and click the 'Get All Checked Abstract(s)' button. To see one abstract at a time, click its [Abstract] link.

January 25, 2023

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    Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to their Evaluation, Validation and Global Implementation
    Sven Deutschmann, Mousumi Paul, Marja Claassen-Willemse, Jonas van den Berg, Pieta IJzerman-Boon, Viviane Grunert da Fonseca, Ellen Brunbech, Lynn Johnson, Chris Knutsen, Lucile Plourde, Joanny Salvas, Philip Villari, Lisa Wysocki and Margit Franz-Riethdorf
    PDA Journal of Pharmaceutical Science and Technology January 2023, pdajpst.2021.012672; DOI: https://doi.org/10.5731/pdajpst.2021.012672

December 26, 2022

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    Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data
    Marc Hogreve
    PDA Journal of Pharmaceutical Science and Technology December 2022, pdajpst.2022.012794; DOI: https://doi.org/10.5731/pdajpst.2022.012794
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    Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
    Robin Wagner, Peter Masatani, Dana Grace, Gianpiero Torraca, Stephanie Moore and David Semin
    PDA Journal of Pharmaceutical Science and Technology December 2022, pdajpst.2021.012710; DOI: https://doi.org/10.5731/pdajpst.2021.012710

November 15, 2022

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    Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology
    Hans Joachim Anders, Daniel Mannle, William Carpenter, Wolfgang Eder, Ivana Heckel, Tobias Gotzen, Corinne Oechslin, Cedric Joosen, Maria Eugenia Giribets Parra, Jason Rose, Vaishali Shah and David L Jones
    PDA Journal of Pharmaceutical Science and Technology November 2022, pdajpst.2022.012742; DOI: https://doi.org/10.5731/pdajpst.2022.012742

October 14, 2022

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    Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma-Mass Spectrometry
    Lydia Breckenridge, Yusuf Oni, Christina Evans, Jason Franck, Sharla Wood, Meng Xu, Erinc Sahin and Brian Zacour
    PDA Journal of Pharmaceutical Science and Technology October 2022, pdajpst.2021.012655; DOI: https://doi.org/10.5731/pdajpst.2021.012655
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    MIT CAACB Risk Assessment Case Study: Assessing virus cross-contamination risk between two simultaneous processes in an open biomanufacturing facility
    Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W Barone, Flora J Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy Springs
    PDA Journal of Pharmaceutical Science and Technology October 2022, pdajpst.2021.012691; DOI: https://doi.org/10.5731/pdajpst.2021.012691
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    Tolerance interval approach for the determination of overfill of liquid parenteral drug products
    Bernhard Schmelzer and Marc Sutter
    PDA Journal of Pharmaceutical Science and Technology October 2022, pdajpst.2022.012743; DOI: https://doi.org/10.5731/pdajpst.2022.012743
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    Characterization of a novel particle in a pharmaceutical drug product
    Stephanie Moore, Peter Masatani, Yasser Nashed-Samuel, Gianni Torraca, Michael Akers, Jeremy Gastwirt, Chakradhar Padala and David Semin
    PDA Journal of Pharmaceutical Science and Technology October 2022, pdajpst.2021.012686; DOI: https://doi.org/10.5731/pdajpst.2021.012686
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    Flexible loading pattern approach in overkill steam sterilization based on the physical properties of steam and thermodynamics of sterilization
    Arnan Ben-David
    PDA Journal of Pharmaceutical Science and Technology October 2022, pdajpst.2021.012708; DOI: https://doi.org/10.5731/pdajpst.2021.012708

September 19, 2022

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    CPV of the Future: AI-powered continued process verification for bioreactor processes
    Andrej Ondracka, Arnau Gasset, Xavier García-Ortega, David Hubmayr, Joeri B.G. van Wijngaarden, José Luis Montesinos-Seguí, Francisco Valero and Toni Manzano
    PDA Journal of Pharmaceutical Science and Technology September 2022, pdajpst.2021.012665; DOI: https://doi.org/10.5731/pdajpst.2021.012665
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    An investigation into the spatial distribution of moisture in freeze-dried products using NIR spectroscopy and chemical imaging
    AZHERUDDIN MOHAMMED, ANTOINE COURNOYER and RYAN GOSSELIN
    PDA Journal of Pharmaceutical Science and Technology September 2022, pdajpst.2020.012443; DOI: https://doi.org/10.5731/pdajpst.2020.012443
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    Investigating Tm method specificity using oligonucleotide sequence variants
    Alexandra H Heussner, Sarina Schuler, Gerd Berger and Melanie Zerulla-Wernitz
    PDA Journal of Pharmaceutical Science and Technology September 2022, pdajpst.2021.012694; DOI: https://doi.org/10.5731/pdajpst.2021.012694

August 19, 2022

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    Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals
    Jennifer Anderson, Christopher Thompson, Kang Cai, Joshua Orchard and Gisela Ferreira
    PDA Journal of Pharmaceutical Science and Technology August 2022, pdajpst.2021.012674; DOI: https://doi.org/10.5731/pdajpst.2021.012674
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    Focus on biorburden culture media and Medical Devices
    Edith Filaire, Vincent Rochette, Elodie Jarousse and Christian Poinsot
    PDA Journal of Pharmaceutical Science and Technology August 2022, pdajpst.2021.012664; DOI: https://doi.org/10.5731/pdajpst.2021.012664
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    Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
    Yusuf Oni, Jason Franck, Christina Evans, Daniel Paniagua, Ankur Kulshrestha and Rao V Mantri
    PDA Journal of Pharmaceutical Science and Technology August 2022, pdajpst.2021.012719; DOI: https://doi.org/10.5731/pdajpst.2021.012719
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    Evaluation of the design, development, and performance of a mass-flow based, open-source buffer manufacturing system
    Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
    PDA Journal of Pharmaceutical Science and Technology August 2022, pdajpst.2021.012660; DOI: https://doi.org/10.5731/pdajpst.2021.012660

July 15, 2022

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    Chemical and Process Parameters Influencing Gelling During Pharmaceutical Wet Media Milling
    Alicia Potuck
    PDA Journal of Pharmaceutical Science and Technology July 2022, pdajpst.2021.012690; DOI: https://doi.org/10.5731/pdajpst.2021.012690
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    A Quality by Design Approach to Microbial Retention Validation
    Annie Leahy, Jennifer Juneau, Kathleen Souza, Corinne Miller, Nhung Nguyen, Herb Lutz and Parag Kolhe
    PDA Journal of Pharmaceutical Science and Technology July 2022, pdajpst.2022.012739; DOI: https://doi.org/10.5731/pdajpst.2022.012739
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    Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
    Allison Scott, Ans Vanbroekhoven, Cedric Joossen, Chris Knutsen, David Govezensky, Hans-Joachim Anders, James Cannon, Joanny Salvas, Michael Dingle, Patrick Hutchins, Petra Merker, Philip Villari, Stephanie Ramsey, Anthony M Cundell, Victoria Navarro and Margit Franz-Riethdorf
    PDA Journal of Pharmaceutical Science and Technology July 2022, pdajpst.2021.012726; DOI: https://doi.org/10.5731/pdajpst.2021.012726

Accepted Articles publish to this page on or about the 15th of each month.

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