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Swissmedic updated requirements for dealing with potential nitrosamine impurities in medicinal products
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2
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205
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February 1, 2024
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Nitrosamine Impurities in Topical Drug Product
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3
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419
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February 3, 2024
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Adoption of CPCA beyond FDA/ EMA
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9
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821
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January 31, 2024
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🇪🇺 EMA/409815/2020 Rev.20
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7
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2037
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January 31, 2024
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Confidence score calculation for the carcinogenic potency categorization approach (CPCA) predictions for N-nitrosamines
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5
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997
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January 11, 2024
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Exploring the CPCA Framework: Defining Acceptable Intake for NDSRIs -Event
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2
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674
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January 10, 2024
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🇹🇼 Taiwan Food and Drug Administration on Nitroso - Salbutamol
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0
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306
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January 9, 2024
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Reflective Beginnings: We have to be in the driver's seat
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4
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436
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January 9, 2024
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N-nitroso Torasemide Impurity formation and control
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23
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1461
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January 5, 2024
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NDSRI in metronidazole
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1
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554
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December 28, 2023
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Redefining Nitrosamine Risks: A Fresh Perspective on Pharmaceuticals -Pub
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16
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1848
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December 17, 2023
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APIC NA Risk Assessment Template
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4
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1887
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December 13, 2023
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MDD for API/DP for Ophthalmic Formulation
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4
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606
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December 12, 2023
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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
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11
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1740
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December 5, 2023
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Control of NDSRIs impurity at Drug Substance (API) specification
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8
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899
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December 5, 2023
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10º encontro Farmacopeia Brasileira
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0
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380
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November 30, 2023
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N-nitroso ticagrelor
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3
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1156
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November 23, 2023
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Autonomous CPCA Web-based calculator FREE
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26
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3239
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November 22, 2023
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CPCA Calculation System (Python Desktop)
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1
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848
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November 22, 2023
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Limit for API having two NDSRI
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9
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1018
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November 21, 2023
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🇨🇭 Swiss Medic Guidelines
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7
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1298
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November 20, 2023
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🇪🇺 EMA - Enhanced AMES test conditions
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0
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526
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November 15, 2023
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Review of NDSRIs in Pharmaceutical Drugs -Pub
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1
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651
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November 13, 2023
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AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position?
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2
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441
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November 9, 2023
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Vilazodone Nitrosamine
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0
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309
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October 31, 2023
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Review of nitrosamine drug substance related impurities (ndsri) in pharmaceutical drugs
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1
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567
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October 31, 2023
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Personal perspective on N-Nitrosamines and recent revision of guidelines
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7
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632
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October 27, 2023
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Reflections on the Impact of Nitrosamine Drug Substance Related Impurities
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0
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327
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October 20, 2023
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CPCA is now included in the updated version of Health Canada’s Guidance on nitrosamine impurities
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15
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2073
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October 13, 2023
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NDSRIs: Analytical Challenges/ Desafios Analíticos
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0
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452
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October 11, 2023
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