Validation

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Considerations for the Validation of Non-CFU Based Bio-Fluorescent Particle Counting Technologies
Cynthia Martindale, Caroline Dreyer, Cedric Joossen, Joanny Salvas, Kim Perkins, Mike Dingle, Petra Merker, Philip Villari, Tony Cundell, Margit Franz-Riethdorf and Patrick Hutchins

PDA Journal of Pharmaceutical Science and Technology November 2025, 79 (6) 694-706; DOI: https://doi.org/10.5731/pdajpst.2024-003036.1
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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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Parenteral Drug Association, Inc.