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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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227
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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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1659
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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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2508
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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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748
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September 4, 2024
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Pfizer Japan Seeks Partial Change of Champix’s Approval towards Re-Supply
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0
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151
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September 2, 2024
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N-Nitroso Tizanidine
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1
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331
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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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1521
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August 30, 2024
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N-nitroso-rivaroxaban amide
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6
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1555
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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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252
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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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106
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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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132
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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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294
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August 22, 2024
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📅 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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993
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August 14, 2024
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AI for NDSRI by Brazil regulatory
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6
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910
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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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372
|
August 6, 2024
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👨💻 Dashboard Containing Published AI Limits
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32
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3720
|
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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272
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July 30, 2024
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🇨🇦 Health Canada updated the guidance and Appendix 1(May 31, 2024)
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18
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2836
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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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529
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February 1, 2024
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🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
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16
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3922
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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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1409
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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
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140
|
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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1175
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July 21, 2023
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Control limit of Nitrosamines and N-nitroso compounds
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2
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474
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July 8, 2024
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Discussion on Cleaning Validation Requirements for Nitrosamines
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3
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1064
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June 24, 2024
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Tetrazole nitrosamines
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1
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292
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June 13, 2024
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Quelles Nitrosamines la Picloxidine est-elle susceptible de former?
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1
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325
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June 12, 2024
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Limit for API having two NDSRI
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14
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2418
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June 11, 2024
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Examining the Use of Surrogates in Combination with The Carcinogenic Potency Categorization Approach when Establishing Acceptable Intake Limits of N-Nitrosamine Impurities
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0
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483
|
June 9, 2024
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Structuring expert review using AOPs: Enabling robust weight-of-evidence assessments for carcinogenicity under ICH S1B(R1)
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0
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285
|
June 9, 2024
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