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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
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17
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4486
|
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
|
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
|
222
|
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
|
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
|
239
|
November 2, 2024
|
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Nitrosamine Mitigation Case Study
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6
|
420
|
October 31, 2024
|
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N-Nitroso Desmethyl Tramadol
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3
|
558
|
October 29, 2024
|
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Software for prediction of NDSRI generation
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5
|
615
|
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
|
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
|
October 15, 2024
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Reactivities of N-Nitrosamines against Common Reagents and Reaction Conditions -Pub
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2
|
322
|
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
|
161
|
October 11, 2024
|
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N-Nitrosamines: bacterial mutagenesis and in vitro metabolism -A MUST READ
|
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9
|
788
|
October 10, 2024
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Dynamics of Nitroso-STG-19 entering the blood circulation
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1
|
126
|
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
|
493
|
October 2, 2024
|
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New paper - Use of molar, instead of weight-based, safety limits
|
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17
|
2884
|
September 25, 2024
|
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🙋♂️ Citizen Petition to FDA on Sitagliptin
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21
|
3541
|
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
|
227
|
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
|
454
|
September 12, 2024
|
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Synthesis and mutagenic risk of avanafil's potential genotoxic impurities -Pub
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0
|
122
|
August 25, 2024
|
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Gut Microbiotica Carcinogen Metabolism - Nitrosamines
|
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5
|
181
|
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
|
379
|
August 6, 2024
|
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N-Nitroso Imidazole content in Clotrimazole
|
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4
|
325
|
August 5, 2024
|
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N-nitroso Tamsulosin identification in Tamsulosin Products by LC-MS/MS
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0
|
269
|
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
|
275
|
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
|
July 31, 2024
|
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Kinetic Model for Assessing Potential Nitrosamine Carcinogenicity
|
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1
|
150
|
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
|
185
|
July 30, 2024
|
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How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits
|
|
0
|
142
|
July 26, 2024
|
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Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies -Pub
|
|
0
|
584
|
July 23, 2024
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