About the Guidance, Documents, Resources category
|
|
0
|
551
|
April 14, 2021
|
πΊπΈ FDA Control of Nitrosamine Impurities in Human Drugs revision2
|
|
50
|
3580
|
March 20, 2025
|
Acceptance criteria for Nitrosamines Method Validation
|
|
3
|
288
|
March 14, 2025
|
CDER Drug Safety Priorities Fiscal Year 2023
|
|
2
|
643
|
February 27, 2025
|
Adjustment of the MDD with CYP inducers?
|
|
2
|
147
|
February 13, 2025
|
EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024
|
|
8
|
1506
|
January 27, 2025
|
ICH M7 & Nitrosamines Impurities -Updates
|
|
15
|
3501
|
January 20, 2025
|
Control Strategy - Testing Frequency
|
|
10
|
370
|
January 20, 2025
|
π²π½ Mexico Q&A Live session streaming
|
|
7
|
644
|
January 6, 2025
|
Critical comparison of BMD and TD50 methods for the calculation of acceptable intakes for N-nitroso compounds -Pub
|
|
0
|
258
|
January 3, 2025
|
CHPA's response to the Control of Nitrosamine Impurities in Human Drugs rev.2
|
|
1
|
371
|
January 2, 2025
|
AI for pharmaceutical legislation, including nitrosamines
|
|
4
|
340
|
December 30, 2024
|
WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products
|
|
4
|
1124
|
December 21, 2024
|
Autonomous CPCA Web-based calculator FREE
|
|
31
|
5632
|
December 12, 2024
|
Nitrosamine Mitigation: A Path to Regulatory Compliance
|
|
0
|
308
|
November 22, 2024
|
π²π½ Mexico Nitrosamine Guide published today
|
|
42
|
2724
|
November 22, 2024
|
Methylene Blue NDSRI
|
|
6
|
503
|
November 22, 2024
|
New EMA Nitrosamine impurities page
|
|
0
|
401
|
November 21, 2024
|
Terbinafine Nitrosamines
|
|
3
|
178
|
November 14, 2024
|
NDSRI limit for N-nitroso Ciprofloxacin
|
|
2
|
261
|
November 1, 2024
|
FDA Statement on Ritonavir and NITMA
|
|
1
|
277
|
October 29, 2024
|
Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
|
|
7
|
522
|
October 29, 2024
|
N-Nitrosamine drug substance related impurities (NDSRIs) β A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da -Pub
|
|
0
|
244
|
October 28, 2024
|
Nitroso Betahistine Impurity C
|
|
2
|
130
|
October 28, 2024
|
Use of L-cysteine as nitrite scavenging
|
|
6
|
254
|
October 25, 2024
|
Selection of Solvent and Positive Control Concentration for Enhanced AMES Test -Pub
|
|
0
|
106
|
October 14, 2024
|
Oral Liquid Formulations
|
|
4
|
187
|
October 14, 2024
|
πΈπ¦ Saudi FDA requesting Nitrosamines Risk Assessments
|
|
5
|
1703
|
October 9, 2024
|
Dietary exposure assessment for volatile N-nitrosamines from food and beverages for the U.S. population -Pub
|
|
0
|
114
|
September 18, 2024
|
NDMA testing in metformin
|
|
5
|
220
|
September 9, 2024
|