Quality by design

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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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Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma
Toni Manzano, Cristina Fernàndez, Toni Ruiz and Hugo Richard

PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 100-118; DOI: https://doi.org/10.5731/pdajpst.2019.011338
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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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Analysis of Particulate Matter in Liquid-Finished Dosage Forms
Jan Duchek and Balazs Havasi

PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 608-625; DOI: https://doi.org/10.5731/pdajpst.2017.008292
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A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control
Cleyton Lage Andrade, Miguel Angel De La O Herrera and Elezer Monte Blanco Lemes

PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 317-331; DOI: https://doi.org/10.5731/pdajpst.2016.007286
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Development of a Premium Quality Plasma-derived IVIg (IQYMUNE^®) Utilizing the Principles of Quality by Design—A Worked-through Case Study
Philippe Paolantonacci, Philippe Appourchaux, Béatrice Claudel, Monique Ollivier, Richard Dennett and Laurent Siret

PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 176-187; DOI: https://doi.org/10.5731/pdajpst.2016.007393
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Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm
Dénes Zalai, Christian Dietzsch and Christoph Herwig

PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 569-580; DOI: https://doi.org/10.5731/pdajpst.2013.00943
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Information Processing: Rate-Based Investigation of Cell Physiological Changes along Design Space Development
Patrick Sagmeister, Patrick Wechselberger and Christoph Herwig

PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 526-541; DOI: https://doi.org/10.5731/pdajpst.2012.00889

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Quality by design

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Parenteral Drug Association, Inc.