Impact of Antioxidant Excipients on N-nitrosamine Formation and Bioequivalence in Metformin Formulations - Pub
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0
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9
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February 6, 2025
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🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
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46
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3170
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January 18, 2025
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CHPA's response to the Control of Nitrosamine Impurities in Human Drugs rev.2
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1
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350
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January 2, 2025
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📅 Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products(CRCG)
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35
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2927
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December 3, 2024
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Requirement after reformulation of existing approved drug product for Europe
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12
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363
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November 12, 2024
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Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program
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6
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428
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October 2, 2024
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FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop
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1
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251
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September 17, 2024
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🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
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16
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3708
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July 28, 2024
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Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
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3
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1168
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July 21, 2023
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AI Limit for Nitroso Nebivolol
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11
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2694
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April 3, 2024
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CDER Drug Safety Priorities Fiscal Year 2023
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1
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585
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February 16, 2024
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Nitrosamine requirements for probiotics
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4
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356
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February 12, 2024
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N-nitroso Vonoprazan AI 96 ng/day- FDA
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5
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3365
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January 29, 2024
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A quick (dumb) question
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10
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1143
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January 22, 2024
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US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2024
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0
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435
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January 18, 2024
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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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647
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November 9, 2023
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N-Nitroso desmethyl bedaquiline
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0
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654
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October 6, 2023
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Total impurities limit if more than one nitrosamine impurities are observed in product
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4
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676
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August 14, 2023
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FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
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11
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3612
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July 27, 2023
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Fiscal Year (FY) 2023 Generic Drug Science and Research Initiatives Public Workshop May 11-12, 2023
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3
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626
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June 15, 2023
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FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals
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2
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919
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June 5, 2023
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N-nitroso Des-methyl Dapoxetine
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12
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1216
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May 31, 2023
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FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
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1
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1529
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May 24, 2023
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Florida District Court dismissed claims that "Ranitidine-NDMA caused cancer -" because of "unreliable methodologies" and lacked "science-based standards"
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0
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360
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December 13, 2022
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Harmonization of AI for NDSRIs with insufficient carcinogenic data
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5
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1095
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July 14, 2022
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FDA - Generic Drug Forum 2022 (Nitrosamine update) 📺
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9
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1061
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April 27, 2022
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