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PDA Journal of Pharmaceutical Science and Technology

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Validation

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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 January 2023, 77 (1) 18-26; DOI: https://doi.org/10.5731/pdajpst.2022.012739
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    Using Analytical Platform Technologies to Support Accelerated Product Development—Concept Review and Case Study
    Stephan O. Krause
    PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 248-262; DOI: https://doi.org/10.5731/pdajpst.2021.012647
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    A Bayesian Statistical Approach to Continuous Qualification of a Bioassay
    Steven J. Novick, Elizabeth Christian, Erika Farmer and Max Tejada
    PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 8-23; DOI: https://doi.org/10.5731/pdajpst.2019.011221
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    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
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    A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation
    Steven Novick, Perceval Sondag, Tim Schofield and Kenneth Miller
    PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 249-263; DOI: https://doi.org/10.5731/pdajpst.2017.008094
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    Demonstration of the Maintaining of the Validated State of a System Used to Generate Water for Injection by Thermocompression Distillation
    Alberto Leyva, Iriac Bisquet, Tania De La Cruz, Leoner Del Arco, Joel Ríos, Rodolfo Valdés, Sonny Robles, Fabian Ugarte and Manuel Montané
    PDA Journal of Pharmaceutical Science and Technology November 2017, 71 (6) 454-461; DOI: https://doi.org/10.5731/pdajpst.2017.007773
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    Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products
    Oliver Gordon, Marcel Goverde, Alexandra Staerk and David Roesti
    PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 206-224; DOI: https://doi.org/10.5731/pdajpst.2016.007450
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    Plasma Decontamination: A Case Study on Kill Efficacy of Geobacillus stearothermophilus Spores on Different Carrier Materials
    Egmont Semmler, Wenzel Novak, Wilf Allinson, Darren Wallis, Nigel Wood, Peter Awakowicz and Joachim Wunderlich
    PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 256-271; DOI: https://doi.org/10.5731/pdajpst.2015.006163
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    Reciprocal Translocation Observed in End-of-Production Cells of a Commercial CHO-Based Process
    Yolande Rouiller, Beate Kleuser, Emiliano Toso, Wolf Palinksy, Mara Rossi, Paola Rossatto, Davide Barberio and Hervé Broly
    PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 540-552; DOI: https://doi.org/10.5731/pdajpst.2015.01063
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    Polymerase Chain Reaction/Rapid Methods Are Gaining a Foothold in Developing Countries
    Suzan Mohammed Ragheb and Luis Jimenez
    PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 239-255; DOI: https://doi.org/10.5731/pdajpst.2014.00979

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© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

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