Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
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17
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4486
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January 10, 2025
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Rat Liver Micronucleus Assay as a Nitrosamine Potency Assessment
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1
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200
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January 8, 2025
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Exploration for Chemical Filter Cartridges that Can Reduce Nitrogen Oxides, a Common Factor in the Formation of Nitrosamines
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0
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222
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December 15, 2024
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Requirement after reformulation of existing approved drug product for Europe
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12
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404
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November 12, 2024
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Resolution of Historically Discordant Ames Test Negative / Rodent Carcinogenicity Positive N-nitrosamines using a Sensitive, OECD-aligned Design-Pub
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0
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239
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November 2, 2024
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Nitrosamine Mitigation Case Study
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6
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420
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October 31, 2024
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N-Nitroso Desmethyl Tramadol
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3
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558
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October 29, 2024
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Software for prediction of NDSRI generation
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5
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615
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October 24, 2024
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Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide impurity formation and its inhibition in bumetanide tablets -Pub
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7
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1161
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October 19, 2024
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Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets -Pub FDA
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2
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193
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October 15, 2024
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Reactivities of N-Nitrosamines against Common Reagents and Reaction Conditions -Pub
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2
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322
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October 15, 2024
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Selection of Solvent and Positive Control Concentration for Enhanced Ames Test Conditions for N-Nitrosamine Compounds -Pub
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0
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161
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October 11, 2024
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N-Nitrosamines: bacterial mutagenesis and in vitro metabolism -A MUST READ
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9
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788
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October 10, 2024
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Dynamics of Nitroso-STG-19 entering the blood circulation
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1
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126
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October 10, 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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493
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October 2, 2024
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New paper - Use of molar, instead of weight-based, safety limits
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17
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2884
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September 25, 2024
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🙋♂️ Citizen Petition to FDA on Sitagliptin
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21
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3541
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June 7, 2024
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Escaping the cohort of concern: in vitro experimental evidence supports non-mutagenicity of N-nitroso-hydrochlorothiazide -Pub
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1
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227
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September 18, 2024
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Can API with amide should considered a potential candidate for forming nitrosamine impurity
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5
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454
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September 12, 2024
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Synthesis and mutagenic risk of avanafil's potential genotoxic impurities -Pub
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0
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122
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August 25, 2024
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Gut Microbiotica Carcinogen Metabolism - Nitrosamines
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5
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181
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August 7, 2024
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Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study
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0
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379
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August 6, 2024
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N-Nitroso Imidazole content in Clotrimazole
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4
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325
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August 5, 2024
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N-nitroso Tamsulosin identification in Tamsulosin Products by LC-MS/MS
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0
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269
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August 1, 2024
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Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub
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2
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275
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July 31, 2024
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Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study -Pub
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1
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270
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July 31, 2024
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Kinetic Model for Assessing Potential Nitrosamine Carcinogenicity
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1
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150
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July 30, 2024
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Nitrosamine Contamination of Pharmaceuticals: Cases in Japan, Formation Mechanisms, Detection Methods, Regulatory Perspectives, and Insights -Pub
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1
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185
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July 30, 2024
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How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits
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0
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142
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July 26, 2024
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Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies -Pub
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0
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584
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July 23, 2024
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