FDA Requirement to inform about nitrosamine risk in ongoing/new clinical trials
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2
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192
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December 13, 2024
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Formation of Nitroso-Omeprazole
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5
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1778
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December 12, 2024
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Methods to reduce false positive results
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1
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215
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December 12, 2024
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Limit of N-nitroso morpholine in Rocuronium Br
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0
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77
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December 12, 2024
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N-nitroso-Impurity C in Metamizol Drug product
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15
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1676
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December 12, 2024
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Autonomous CPCA Web-based calculator FREE
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31
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5441
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December 12, 2024
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Limits for small nitrosamines
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10
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541
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December 6, 2024
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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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Free webinar: From Ambiguity to Action, The FDA's New Nitrosamine Guidance
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1
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594
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December 2, 2024
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NDMA production in the presence of formaldehyde: Competition between acid-catalyzed and formaldehyde-catalyzed reactions
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3
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234
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December 2, 2024
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吲哚类亚硝胺杂质怎么进行评估、计算ai值 - How to evaluate and calculate the AI value of indole nitrosamine impurities
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1
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212
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December 1, 2024
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Estimation of Nitrosamines from Nitrites level
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8
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1525
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December 1, 2024
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FY 2025 GDUFA Science and Research Priorities
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0
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241
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November 28, 2024
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⚖️ Risk assessment not strong enough, specifically on related impurities containing secondary amine
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20
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1937
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November 28, 2024
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N-Nitroso Sertraline
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7
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370
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November 27, 2024
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Low nitrite excipients
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11
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2333
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November 27, 2024
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Phathom Pharmaceuticals reported nitrosamine impurity in their vonoprazan-based products
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24
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2939
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November 26, 2024
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Nitrosamine Mitigation: A Path to Regulatory Compliance
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0
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298
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November 22, 2024
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🇲🇽 Mexico Nitrosamine Guide published today
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42
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2620
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November 22, 2024
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Tipiracil NDSRI
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0
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72
|
November 22, 2024
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Nitrosamnes in PMs & Excipients Questions
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5
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992
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November 22, 2024
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Methylene Blue NDSRI
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6
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466
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November 22, 2024
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New EMA Nitrosamine impurities page
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0
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388
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November 21, 2024
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Small Nitrosamines in excipeints
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11
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380
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November 21, 2024
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Morpholine group in molecular structure
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8
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219
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November 21, 2024
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N-Nitroso Metoprolol
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0
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121
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November 20, 2024
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How to decide if one anticancer drug is for advanced cancer?
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8
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394
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November 20, 2024
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N-nitroso Tulathromycin
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1
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102
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November 19, 2024
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活性炭成为亚硝酸根来源的风险如何控制?
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3
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172
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November 16, 2024
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Question about the N-nitroso-bicisate
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1
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124
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November 15, 2024
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