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Acceptance criteria for Nitrosamines Method Validation
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3
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445
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March 14, 2025
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CDER Drug Safety Priorities Fiscal Year 2023
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2
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650
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February 27, 2025
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Adjustment of the MDD with CYP inducers?
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2
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159
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February 13, 2025
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EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024
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8
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2362
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January 27, 2025
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ICH M7 & Nitrosamines Impurities -Updates
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15
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4708
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January 20, 2025
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Control Strategy - Testing Frequency
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10
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444
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January 20, 2025
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🇲🇽 Mexico Q&A Live session streaming
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7
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723
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January 6, 2025
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Critical comparison of BMD and TD50 methods for the calculation of acceptable intakes for N-nitroso compounds -Pub
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0
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299
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January 3, 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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396
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January 2, 2025
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AI for pharmaceutical legislation, including nitrosamines
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4
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386
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December 30, 2024
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WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products
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4
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1172
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December 21, 2024
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Methylene Blue NDSRI
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6
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589
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November 22, 2024
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New EMA Nitrosamine impurities page
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0
|
467
|
November 21, 2024
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Terbinafine Nitrosamines
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3
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273
|
November 14, 2024
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NDSRI limit for N-nitroso Ciprofloxacin
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2
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334
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November 1, 2024
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FDA Statement on Ritonavir and NITMA
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1
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392
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October 29, 2024
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Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
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7
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587
|
October 29, 2024
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N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da -Pub
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0
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310
|
October 28, 2024
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Nitroso Betahistine Impurity C
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2
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167
|
October 28, 2024
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Use of L-cysteine as nitrite scavenging
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6
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369
|
October 25, 2024
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Selection of Solvent and Positive Control Concentration for Enhanced AMES Test -Pub
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0
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128
|
October 14, 2024
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Oral Liquid Formulations
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4
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227
|
October 14, 2024
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🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
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5
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1836
|
October 9, 2024
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Dietary exposure assessment for volatile N-nitrosamines from food and beverages for the U.S. population -Pub
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0
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128
|
September 18, 2024
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NDMA testing in metformin
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5
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259
|
September 9, 2024
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Vildaglibtin and Metformin in combinationy
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1
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560
|
October 17, 2023
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USP - CPCA Nitrosamines Case Study
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7
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1563
|
August 30, 2024
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Resources to help educate reluctant excipient suppliers?
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7
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351
|
August 28, 2024
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Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
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1
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115
|
August 27, 2024
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Analytical methodologies to detect N-nitrosamine impurities in active pharmaceutical ingredients, drug products and other matrices -Pub
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0
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426
|
August 27, 2024
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