Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub
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16
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502
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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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123
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October 10, 2024
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πΈπ¦ Saudi FDA requesting Nitrosamines Risk Assessments
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5
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1666
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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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4089
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September 30, 2024
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π© CPCA Calculation Tool (excel-based) -Updated
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87
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10977
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September 27, 2024
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Multiple Secondary Amine Groups in the Same Molecule
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2
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217
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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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213
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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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22
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1630
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September 5, 2024
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EMA Q&A Appendix 1 is updated Sept 4, 2024
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18
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1797
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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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515
|
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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421
|
September 3, 2024
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Pfizer Japan Seeks Partial Change of Champixβs Approval towards Re-Supply
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0
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145
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September 2, 2024
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N-Nitroso Tizanidine
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1
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253
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August 31, 2024
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USP - CPCA Nitrosamines Case Study
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7
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1463
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August 30, 2024
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N-nitroso-rivaroxaban amide
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6
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1452
|
August 29, 2024
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How much Amine and Nitrating agent "Stoichiometric Ratio" required for formation of Nitrosamine impurities?
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3
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200
|
August 28, 2024
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Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
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1
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101
|
August 27, 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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0
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114
|
August 25, 2024
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Suppressing Nitrosamine Drug Substance Related Impurities by Solid Dispersion
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1
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273
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August 22, 2024
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π
FDA - CRCG Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products -Event
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1
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966
|
August 14, 2024
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AI for NDSRI by Brazil regulatory
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6
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845
|
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
|
324
|
August 6, 2024
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π¨βπ» Dashboard Containing Published AI Limits
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32
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3591
|
August 2, 2024
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The clinical and regulatory status of NDSRI: A global imperative -Pub
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1
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249
|
July 30, 2024
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π¨π¦ Health Canada updated the guidance and Appendix 1(May 31, 2024)
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18
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2543
|
July 30, 2024
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Swissmedic updated requirements for dealing with potential nitrosamine impurities in medicinal products
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2
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517
|
February 1, 2024
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πΊπΈ FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
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16
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3708
|
July 28, 2024
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Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
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8
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1369
|
July 27, 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
|
125
|
July 26, 2024
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Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
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3
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1168
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July 21, 2023
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