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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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272
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November 2, 2024
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Nitrosamine Mitigation Case Study
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6
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477
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October 31, 2024
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N-Nitroso Desmethyl Tramadol
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3
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887
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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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702
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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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1232
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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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234
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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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357
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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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192
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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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825
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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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140
|
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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592
|
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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2991
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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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3600
|
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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259
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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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654
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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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153
|
August 25, 2024
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Gut Microbiotica Carcinogen Metabolism - Nitrosamines
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5
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201
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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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449
|
August 6, 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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306
|
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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336
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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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337
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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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162
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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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198
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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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149
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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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625
|
July 23, 2024
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Quantum Mechanical Assessment of Nitrosamine Potency -Pub
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3
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489
|
July 15, 2024
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AZIDO Impurities Topic
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4
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1371
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July 11, 2024
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A Case to Support the Continued Use of Rifampin in Clinical Drug–Drug Interaction Studies -Pub
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0
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186
|
July 10, 2024
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Non-mutagenic, carcinogenic impurities
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3
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692
|
June 30, 2024
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Discussion on Cleaning Validation Requirements for Nitrosamines
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3
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1130
|
June 24, 2024
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