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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.

March 16, 2022

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    A Systematic Approach for the Evaluation, Validation and Implementation of Automated Colony Counting Systems
    Sven Deutschmann, Bill Carpenter, Caroline Duignan, Chris Knutsen, Joanny Salvas, Lisa Wysocki, Lucile Plourde, Lynn Johnson, Wolfgang Eder and Margit Franz-Riethdorf
    PDA Journal of Pharmaceutical Science and Technology March 2022, pdajpst.2021.012646; DOI: https://doi.org/10.5731/pdajpst.2021.012646
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    Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform
    E. Lynne Kelley, Andrea Fernandes, Marc Pelletier, Eri Ashley Takami, Christine Emery, Bobby Dyer, Mary V. Jacoski, Valery Lozko, Bart Burgess and Richard H. Smith
    PDA Journal of Pharmaceutical Science and Technology March 2022, pdajpst.2021.012670; DOI: https://doi.org/10.5731/pdajpst.2021.012670
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    Container Closure Integrity Test Method Development on Vials Stored at -80°C Using Headspace Carbon Dioxide Analysis
    Ken G Victor, Allison Alix Caudill and James Veale
    PDA Journal of Pharmaceutical Science and Technology March 2022, pdajpst.2021.012641; DOI: https://doi.org/10.5731/pdajpst.2021.012641

February 15, 2022

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    Do Plant Isolates have a Role in Method Suitability and Growth Promotion Testing in the Microbiology Laboratory? Is it a Matter of Science versus Compliance?
    Dennis E. Guilfoyle and Anthony M. Cundell
    PDA Journal of Pharmaceutical Science and Technology February 2022, pdajpst.2021.012675; DOI: https://doi.org/10.5731/pdajpst.2021.012675
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    Microbial Contamination in Water Systems
    Fritz Roeder and Tim Sandle
    PDA Journal of Pharmaceutical Science and Technology February 2022, pdajpst.2021.012636; DOI: https://doi.org/10.5731/pdajpst.2021.012636
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    Quantification and Stability Impact Assessment of Drop Stresses in Biologic Drug Products
    Mahsa Siavashpouri, Christina Bailey-Hytholt, Jene-Rene Authelin and Sanket Patke
    PDA Journal of Pharmaceutical Science and Technology February 2022, pdajpst.2021.012722; DOI: https://doi.org/10.5731/pdajpst.2021.012722
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    Principles for Management of Extractables and Leachables in Ophthalmic Drug Products
    Christopher Houston, Andrea Desantis Rodrigues, Brenda Birkestrand Smith, Tao Wang and Mary Richardson
    PDA Journal of Pharmaceutical Science and Technology February 2022, pdajpst.2022.012744; DOI: https://doi.org/10.5731/pdajpst.2022.012744
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    Tailored media-fill test protocols inspired by 68Ga kit-based radiopharmaceuticals
    Charlotte Donze, Lea Rubira, Pierre Olivier Kotzki, Emmanuel Deshayes and Cyril Fersing
    PDA Journal of Pharmaceutical Science and Technology February 2022, pdajpst.2021.012657; DOI: https://doi.org/10.5731/pdajpst.2021.012657

January 14, 2022

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    A predictive modelling approach to support the overfill volume definition of liquid-in-vial drug products
    Sébastien Dasnoy, Laura Simonin, Soizic Radulovic, Andy White, Jean-François Decoster and Laurence Denis
    PDA Journal of Pharmaceutical Science and Technology January 2022, pdajpst.2021.012658; DOI: https://doi.org/10.5731/pdajpst.2021.012658
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    Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) Relevant to Parenteral Extractables and Leachables (E&Ls)
    Melisa J. Masuda-Herrera, Joel P. Bercu, Thomas H. Broschard, Anders Burild, Catrin Hasselgren, Patricia Parris, Lucie C. Ford, Jessica Graham, Brad Stanard, Michele Comerford, Daniel Lettiere, Steffen Erler, Courtney M. Callis, Eric Morinello, Wolfgang Muster, Elizabeth A. Martin, Troy R. Griffin, Lee Nagao and Maureen Cruz
    PDA Journal of Pharmaceutical Science and Technology January 2022, pdajpst.2021.012693; DOI: https://doi.org/10.5731/pdajpst.2021.012693
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    Systematic design, generation, and application of synthetic datasets for flow cytometry
    Melissa Cheung, Jonathan J Campbell, Robert J Thomas, Julian Braybrook and Jon Petzing
    PDA Journal of Pharmaceutical Science and Technology January 2022, pdajpst.2021.012659; DOI: https://doi.org/10.5731/pdajpst.2021.012659

December 15, 2021

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    Proceedings of 2019 Viral Clearance Symposium, Session 5: Viral Inactivation
    Junfen Ma
    PDA Journal of Pharmaceutical Science and Technology December 2021, pdajpst.2021.012681; DOI: https://doi.org/10.5731/pdajpst.2021.012681
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    Proceedings of 2019 Viral Clearance Symposium, Session 2: New Modalities in Chromatography and Adsorptive Filters
    Rachel Specht and Astrid Schwantes
    PDA Journal of Pharmaceutical Science and Technology December 2021, pdajpst.2021.012678; DOI: https://doi.org/10.5731/pdajpst.2021.012678
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    Proceedings of 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies
    Simon Reitz and Astrid Schwantes
    PDA Journal of Pharmaceutical Science and Technology December 2021, pdajpst.2021.012677; DOI: https://doi.org/10.5731/pdajpst.2021.012677
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    Proceedings of 2019 Viral Clearance Symposium, Session 3: Continuous Processing
    Scott Lute and Rachel Specht
    PDA Journal of Pharmaceutical Science and Technology December 2021, pdajpst.2021.012679; DOI: https://doi.org/10.5731/pdajpst.2021.012679
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    Proceedings of 2019 Viral Clearance Symposium: Introduction
    Sean O'Donnell
    PDA Journal of Pharmaceutical Science and Technology December 2021, pdajpst.2021.012676; DOI: https://doi.org/10.5731/pdajpst.2021.012676
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    Proceedings of 2019 Viral Clearance Symposium, Session 7: Cell Banks and U.S. Pharmacopeia
    Sean O'Donnell
    PDA Journal of Pharmaceutical Science and Technology December 2021, pdajpst.2021.012683; DOI: https://doi.org/10.5731/pdajpst.2021.012683
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    Proceedings of 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding
    David Roush and Johannes Blümel
    PDA Journal of Pharmaceutical Science and Technology December 2021, pdajpst.2021.012680; DOI: https://doi.org/10.5731/pdajpst.2021.012680
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    Proceedings of 2019 Viral Clearance Symposium, Session 6: Virus Retentive Filtration
    Sean O'Donnell and Glen Bolton
    PDA Journal of Pharmaceutical Science and Technology December 2021, pdajpst.2021.012682; DOI: https://doi.org/10.5731/pdajpst.2021.012682
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    Proceedings of the 2019 Viral Clearance Symposium, Session 8: Conference Summary- Key Discussion and Outcomes, Pending Questions, and Proposed Experiments and Actions
    Glen Bolton
    PDA Journal of Pharmaceutical Science and Technology December 2021, pdajpst.2021.012684; DOI: https://doi.org/10.5731/pdajpst.2021.012684

November 15, 2021

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    A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation
    Dennis Jenke, Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde and Jan Baeten
    PDA Journal of Pharmaceutical Science and Technology November 2021, pdajpst.2021.012692; DOI: https://doi.org/10.5731/pdajpst.2021.012692
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    A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
    Roman Mathaes, Klaus Wuchner, David Riesop, Daniel Wagner, Sascha Dreher, Florian Woelfle, Prudvi Raj Mudumala, Debora Bonvin, Christian Müller, Kerstin Traub Hoffmann and Henri Hebting
    PDA Journal of Pharmaceutical Science and Technology November 2021, pdajpst.2021.012633; DOI: https://doi.org/10.5731/pdajpst.2021.012633
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    Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data when Screening for Extractables and Leachables by GC/MS?
    Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten and Jean-Marie Beusen
    PDA Journal of Pharmaceutical Science and Technology November 2021, pdajpst.2021.012673; DOI: https://doi.org/10.5731/pdajpst.2021.012673

October 18, 2021

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    Using Analytical Platform Technologies to Support Accelerated Product Development – Concept Review and Case Study
    Stephan Oswald Krause
    PDA Journal of Pharmaceutical Science and Technology October 2021, pdajpst.2021.012647; DOI: https://doi.org/10.5731/pdajpst.2021.012647

September 16, 2021

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    Sterility Assurance-Current & Future State
    Edward C. Tidswell, James P. Agalloco and Radha Tirumalai
    PDA Journal of Pharmaceutical Science and Technology September 2021, pdajpst.2020.012526; DOI: https://doi.org/10.5731/pdajpst.2020.012526

August 16, 2021

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    Replacing the emulsion for bake-on siliconization of containers − comparison of emulsion stability and container performance in the context of protein formulations
    Fabian Moll, Karoline Bechtold-Peters, James Mellman, Jurgen Sigg and Wolfgang Friess
    PDA Journal of Pharmaceutical Science and Technology August 2021, pdajpst.2021.012640; DOI: https://doi.org/10.5731/pdajpst.2021.012640

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

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