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Personal perspective on N-Nitrosamines and recent revision of guidelines
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7
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657
|
October 27, 2023
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FDA - Pharmaceutical Quality Symposium
|
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1
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725
|
November 1, 2023
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Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
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4
|
830
|
May 11, 2024
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TALK SERIES: Navigating Nitrosamine and NDSRIs regulations with Dr. Reddy´s Laboratories
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1
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588
|
February 11, 2024
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Bard responds to Nitrosamine Risk Assessment scheme
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1
|
513
|
January 16, 2024
|
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EMA Q&A Rev. 19 (EMA/409815/2020 Rev.19)
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0
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1423
|
November 13, 2023
|
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New Guidance from Malaysia's NPRA 03 July 2023
|
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0
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635
|
July 12, 2023
|
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Reflective Beginnings: We have to be in the driver's seat
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4
|
469
|
January 9, 2024
|
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The predecesor to ICH M7
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0
|
528
|
June 7, 2023
|
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🇪🇺 EMA Q&A Rev. 18 EMA/409815/2020 - Deadlines
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2
|
1024
|
October 3, 2023
|
|
Metabolic activation of short-chain alkyl N-nitrosamines using Aroclor 1254 or phenobarbital/beta-naphthoflavone-induced rat or hamster S9 – a comparative analysis -Pub
|
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4
|
381
|
February 2, 2024
|
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Novel LC-MSMS Method including for E&L of packaging materials
|
|
0
|
408
|
January 22, 2024
|
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Nitrosamines Severity (impact) - a quantitative model proposal?
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3
|
760
|
February 12, 2024
|
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👨💻 Nitrosamines Trends in Google
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0
|
364
|
January 8, 2024
|
|
10º encontro Farmacopeia Brasileira
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0
|
400
|
November 30, 2023
|
|
Omission of specification <10% AI
|
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2
|
652
|
September 12, 2023
|
|
Sixth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
|
|
4
|
488
|
January 30, 2024
|
|
🇦🇺 Australia / Nitrosamine impurities in medicines updates
|
|
0
|
622
|
November 2, 2023
|
|
📅 Ascorbic Acid And Alpha-Tocopherol As Nitrite Scavengers - An Elegant And Simple Solution To Mitigate Nitrosamines In Drug Products -Event
|
|
0
|
565
|
April 5, 2024
|
|
🇬🇧 Medicines: MAH' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing
|
|
2
|
785
|
January 23, 2024
|
|
🇪🇺 EDQM - top 10 deficiencies observed in new CEP applications
|
|
0
|
572
|
March 14, 2024
|
|
🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
|
|
2
|
1036
|
April 17, 2024
|
|
Managing Nitrite Impurities: A Combined Supplier-Manufacturer View to Nitrosamine Risks
|
|
3
|
835
|
October 3, 2023
|
|
SOT posters and talks, (shared posters -update)
|
|
3
|
455
|
April 10, 2024
|
|
Formaldehyde Catalysis of Nitrosamine Formation
|
|
1
|
331
|
February 1, 2024
|
|
Nitrosamine Impurities Deadline: Are Your Products Compliant?
|
|
6
|
607
|
December 6, 2023
|
|
In Silico Prediction of N-Nitrosamine Formation Pathways of Pharmaceutical Products -Pub
|
|
0
|
421
|
February 8, 2024
|
|
Risk characterization of N-nitrosodimethylamine in pharmaceuticals -Pub
|
|
6
|
559
|
February 16, 2024
|
|
IPA-QF Guidance on Nitrosamines Impurities
|
|
0
|
698
|
August 18, 2023
|
|
57th Congress of the European Societies of Toxicology (EUROTOX 2023)
|
|
0
|
422
|
September 18, 2023
|
|
Formation of N-Nitrosamines by Reaction of Secondary Dialkylamines with Trace Levels of Nitrite in Aqueous Solution: An Automated Experimental and Kinetic Modeling Study Using Di-n-butylamine
|
|
2
|
869
|
December 30, 2023
|
|
Top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023
|
|
1
|
484
|
February 9, 2024
|
|
🇺🇸 FDA NDSRI Limits update -Mar 2024
|
|
6
|
976
|
April 22, 2024
|
|
Strategies for Mitigating In-Source Fragmentation in NDSRI Analysis using LC-MS
|
|
2
|
1270
|
July 3, 2023
|
|
Planilha CPCA na prática
|
|
0
|
318
|
August 6, 2023
|
|
Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs)
|
|
1
|
733
|
May 31, 2023
|
|
Request for risk assessment and confirmatory testing for nortriptyline containing products
|
|
4
|
429
|
April 3, 2024
|
|
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products
|
|
1
|
710
|
June 5, 2023
|
|
Nitrosamines: Mass Spectrometry-Based Analytical Procedures
|
|
5
|
1927
|
May 20, 2024
|
|
Why do some mutagenic N-nitrosamines not require metabolic activation?
|
|
0
|
326
|
November 15, 2023
|
|
🇨🇦 Health Canada extended deadline?
|
|
4
|
550
|
October 23, 2023
|
|
Acrostic - facilitating, supporting and documenting read-across!
|
|
4
|
500
|
April 8, 2024
|
|
🇪🇺 EMA - Enhanced AMES test conditions
|
|
0
|
574
|
November 15, 2023
|
|
Quality Officer Call for a New approach to Reduce Post Approval Complexity
|
|
0
|
245
|
February 28, 2024
|
|
Read-across Masterclass: How To Facilitate Your Acceptable Intake Limit Setting For Nitrosamines
|
|
0
|
278
|
March 7, 2024
|
|
Review of NDSRIs in Pharmaceutical Drugs -Pub
|
|
1
|
667
|
November 13, 2023
|
|
Singapore: HSA issues retail-level recalls for batches of Apo-Amitriptyline and Apo-Acyclovir tablets due to nitrosamine impurity concerns
|
|
0
|
457
|
September 4, 2023
|
|
Webinars (available on demand)
|
|
0
|
477
|
June 20, 2023
|
|
Optimized method development strategies for the quantification of small and complex N-nitrosamines impurities
|
|
0
|
415
|
August 25, 2023
|
|
Low Nitrite Excipients - it’s happening
|
|
2
|
795
|
June 30, 2023
|