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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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29
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2159
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November 13, 2024
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Analytical procedure development and proposed established conditions: A case study of a mass spectrometry based NDSRI analytical procedure -Pub
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19
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1551
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November 6, 2024
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⁉️ Duloxetine Impurity NDSRI
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7
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584
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November 1, 2024
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Hypothetical Nitrosamine in 1-H Indazole / CPCA Approach
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3
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108
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October 31, 2024
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📅 Analytical challenges and the effective management of nitrosamines: The evolving landscape of NDSRI analysis
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3
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433
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October 30, 2024
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What is CPCA Score for “N-nitroso of 3-Amino-1,2,4-triazole"
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5
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178
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October 30, 2024
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N-Nitroso Desmethyl Tramadol
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3
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253
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October 29, 2024
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Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA) -Pub
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0
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114
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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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486
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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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165
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October 28, 2024
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N-nitroso-Duloxetine recall back in the news!
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11
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1257
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October 27, 2024
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🛑 N-nitroso Ticagrelor
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12
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2632
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October 25, 2024
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Software for prediction of NDSRI generation
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5
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477
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October 24, 2024
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N-Nitroso duloxetine methods from SwissMedic and Taiwan FDA
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0
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80
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October 24, 2024
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Nationwide recall of duloxetine
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0
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174
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October 23, 2024
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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub
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16
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401
|
October 21, 2024
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Dynamics of Nitroso-STG-19 entering the blood circulation
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1
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119
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October 10, 2024
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🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
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5
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1606
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October 9, 2024
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Case Studies for CPCA Scoring
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18
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4005
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September 30, 2024
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🖩 CPCA Calculation Tool (excel-based) -Updated
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87
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10590
|
September 27, 2024
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Multiple Secondary Amine Groups in the Same Molecule
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2
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207
|
September 26, 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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202
|
September 18, 2024
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Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs
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23
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1603
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September 8, 2024
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EMA Q&A Appendix 1 is updated Sept 4, 2024
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18
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1262
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September 6, 2024
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FDA updated information on recommended AI Sept 4, 2024
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1
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403
|
September 4, 2024
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Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential -Pub
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7
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384
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September 3, 2024
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Pfizer Japan Seeks Partial Change of Champix’s Approval towards Re-Supply
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0
|
137
|
September 2, 2024
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N-Nitroso Tizanidine
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1
|
198
|
August 31, 2024
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USP - CPCA Nitrosamines Case Study
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7
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1426
|
August 30, 2024
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N-nitroso-rivaroxaban amide
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6
|
1349
|
August 29, 2024
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