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Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma
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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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Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap
Martin J. Lipa, Anne Greene and Nuala Calnan

PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 64-90; DOI: https://doi.org/10.5731/pdajpst.2020.011825
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Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads
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PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 91-99; DOI: https://doi.org/10.5731/pdajpst.2019.011304
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Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data
K. Rao Gurijala and Andrew Barnett

PDA Journal of Pharmaceutical Science and Technology February 2021, pdajpst.2020.011791; DOI: https://doi.org/10.5731/pdajpst.2020.011791
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The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the AET Adjusted for Response Factor Variation
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PDA Journal of Pharmaceutical Science and Technology November 2020, pdajpst.2020.012013; DOI: https://doi.org/10.5731/pdajpst.2020.012013
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Container Closure Integrity Test using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
Allison Alix Caudill, Ken G Victor, Michael Timmins and James Veale

PDA Journal of Pharmaceutical Science and Technology October 2020, pdajpst.2020.011502; DOI: https://doi.org/10.5731/pdajpst.2020.011502
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Risk mitigation of drug shortages - A new concept for vials designed to improve fill & finish performance
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PDA Journal of Pharmaceutical Science and Technology September 2020, pdajpst.2020.011585; DOI: https://doi.org/10.5731/pdajpst.2020.011585
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Development of generic equivalence margins for early stage implementation of equivalence testing for potency assays
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PDA Journal of Pharmaceutical Science and Technology September 2020, pdajpst.2020.012096; DOI: https://doi.org/10.5731/pdajpst.2020.012096
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Control Strategy Approach for a Well-Characterized Vaccine Drug Product
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PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
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Risk Assessment Approach to Microbiological Controls of Cell Therapies
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Parenteral Drug Association, Inc.