|
Duloxetine Impurity NDSRI
|
|
2
|
230
|
October 11, 2024
|
|
Dynamics of Nitroso-STG-19 entering the blood circulation
|
|
1
|
99
|
October 10, 2024
|
|
📅 Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products(CRCG)
|
|
5
|
884
|
October 9, 2024
|
|
🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
|
|
5
|
1565
|
October 9, 2024
|
|
Analytical challenges and the effective management of nitrosamines: The evolving landscape of NDSRI analysis
|
|
1
|
224
|
October 7, 2024
|
|
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub
|
|
14
|
287
|
October 3, 2024
|
|
Case Studies for CPCA Scoring
|
|
18
|
3960
|
September 30, 2024
|
|
🖩 CPCA Calculation Tool (excel-based) -Updated
|
|
87
|
10369
|
September 27, 2024
|
|
Multiple Secondary Amine Groups in the Same Molecule
|
|
2
|
189
|
September 26, 2024
|
|
N-Nitroso Desmethyl Tramadol
|
|
0
|
132
|
September 25, 2024
|
|
Escaping the cohort of concern: in vitro experimental evidence supports non-mutagenicity of N-nitroso-hydrochlorothiazide -Pub
|
|
1
|
195
|
September 18, 2024
|
|
Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs
|
|
23
|
1588
|
September 8, 2024
|
|
EMA Q&A Appendix 1 is updated Sept 4, 2024
|
|
18
|
1011
|
September 6, 2024
|
|
FDA updated information on recommended AI Sept 4, 2024
|
|
1
|
355
|
September 4, 2024
|
|
Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential -Pub
|
|
7
|
371
|
September 3, 2024
|
|
Pfizer Japan Seeks Partial Change of Champix’s Approval towards Re-Supply
|
|
0
|
132
|
September 2, 2024
|
|
N-Nitroso Tizanidine
|
|
1
|
168
|
August 31, 2024
|
|
USP - CPCA Nitrosamines Case Study
|
|
7
|
1370
|
August 30, 2024
|
|
N-nitroso-rivaroxaban amide
|
|
6
|
1310
|
August 29, 2024
|
|
How much Amine and Nitrating agent "Stoichiometric Ratio" required for formation of Nitrosamine impurities?
|
|
3
|
163
|
August 28, 2024
|
|
Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
|
|
1
|
97
|
August 27, 2024
|
|
Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential-Pub
|
|
0
|
103
|
August 25, 2024
|
|
Suppressing Nitrosamine Drug Substance Related Impurities by Solid Dispersion
|
|
1
|
263
|
August 22, 2024
|
|
Analytical procedure development and proposed established conditions: A case study of a mass spectrometry based NDSRI analytical procedure -Pub
|
|
17
|
1327
|
August 18, 2024
|
|
📅 FDA - CRCG Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products -Event
|
|
1
|
894
|
August 14, 2024
|
|
AI for NDSRI by Brazil regulatory
|
|
6
|
786
|
August 7, 2024
|
|
Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study
|
|
0
|
278
|
August 6, 2024
|
|
👨💻 Dashboard Containing Published AI Limits
|
|
32
|
3311
|
August 2, 2024
|
|
The clinical and regulatory status of NDSRI: A global imperative -Pub
|
|
1
|
223
|
July 30, 2024
|
|
🇨🇦 Health Canada updated the guidance and Appendix 1(May 31, 2024)
|
|
18
|
2207
|
July 30, 2024
|