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Risk Assessment and Management Strategy of Two New Nitrosamine Drug Substance Related Impurities (NDSRIs) in a Pharmaceutical Drug Product for the Treatment of a Rare Disease- from Prediction to Control-Pub
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0
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618
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January 29, 2025
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📽 Introduction to Using (Q)SAR for the Assessment of Potential Mutagenicity of Drug Impurities
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0
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307
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October 30, 2024
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🖥 Berkeley Madonna Software for Nitrosation Kinetic Calculations
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5
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943
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October 10, 2024
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Anybody inquired about Nitrosamines in Poly bags?
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8
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1783
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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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362
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August 28, 2024
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Regulatory Highlights(OPR&D)
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15
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2404
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August 21, 2024
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Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day
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29
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7097
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August 19, 2024
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TK6 Cell Line Panel
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5
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269
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July 29, 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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1571
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July 27, 2024
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Useful publications to sharpen your skills for reviewing DS risk assessment
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0
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382
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July 25, 2024
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Risk analysis of nitrosamine impurities in liquid products (essences and flavors)
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3
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879
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June 28, 2024
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A New Framework for Identifying Nitrosamine Risks
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1
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686
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June 13, 2024
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Nitrosamine in Azathioprine
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4
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999
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May 14, 2024
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Nitrosamines Risk in Pharmaceutical Waters
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6
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4271
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May 8, 2024
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Risk Analysis for Ergotamine Tartrate
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4
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468
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April 22, 2024
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Risk Assessment Study of Nitrosamines for the API Temozolomide Industrial Process -Pub
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1
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2090
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February 6, 2024
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Application of duplex sequencing to evaluate mutagenicity -Pub
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1
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425
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March 14, 2024
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Is it possible to observe N-nitrosamines formation from oximes? Do you have any reference to support the risk assessment for nitrosamine formation from the reaction of these functional groups in the presence of nitrosating agents? Thank you
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2
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382
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February 27, 2024
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Skipping risk assessment
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4
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476
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February 11, 2024
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Nitrosamines risk assessment and batch results
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4
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673
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January 23, 2024
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Duplex Sequencing - Future of mutagenicity assessment
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3
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696
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January 23, 2024
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Bard responds to Nitrosamine Risk Assessment scheme
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1
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792
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January 16, 2024
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Potential Event with USP & Health Authorities
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6
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792
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December 28, 2023
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QSAR Models - Ames/QSAR International Challenge Project - 21 teams from 11 countries
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0
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523
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December 12, 2023
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Nitrosamine Risk Assessment for Purified Water Used in Manufacturing for Pilot Bio/Clinical Trial Batches
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2
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1627
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October 22, 2023
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Nitrosamines risk assessments for Topical herbal extracts
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1
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574
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September 20, 2023
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Enhanced Ames Test Conditions for N-nitrosamines (Q&A Rev.16)
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9
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3551
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September 13, 2023
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Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N‑Nitrosamine Risk Assessments
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4
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1536
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September 7, 2023
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Forced Degradation and the NAP test
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3
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911
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September 2, 2023
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Potency score for protected hydroxy group
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2
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498
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August 22, 2023
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