|
QSAR Models - Ames/QSAR International Challenge Project - 21 teams from 11 countries
|
|
0
|
480
|
December 12, 2023
|
|
MDD for API/DP for Ophthalmic Formulation
|
|
4
|
989
|
December 12, 2023
|
|
NDSRI/ Guidance
|
|
2
|
480
|
December 12, 2023
|
|
Nitrosamine due to preservative in ophthalmic
|
|
3
|
854
|
December 8, 2023
|
|
Risk for dossier submission link to secondary amine present on API related impurity
|
|
0
|
365
|
December 8, 2023
|
|
Nitrosamine Impurities Deadline: Are Your Products Compliant?
|
|
6
|
703
|
December 6, 2023
|
|
Deadline for reporting changes
|
|
2
|
487
|
December 5, 2023
|
|
Control of NDSRIs impurity at Drug Substance (API) specification
|
|
8
|
1340
|
December 5, 2023
|
|
8th Impurities: Genotoxic, Nitrosamine, & Beyond Summit
|
|
1
|
1067
|
December 1, 2023
|
|
10º encontro Farmacopeia Brasileira
|
|
0
|
516
|
November 30, 2023
|
|
Differences of limit of EMA and FDA regulatory for category 1
|
|
0
|
579
|
November 23, 2023
|
|
CPCA Calculation System (Python Desktop)
|
|
1
|
1472
|
November 22, 2023
|
|
EMA Q&A Appendix 1 update posted Sept 28,2023
|
|
13
|
1817
|
November 22, 2023
|
|
🇨🇭 Swiss Medic Guidelines
|
|
7
|
1702
|
November 20, 2023
|
|
Automated Total Nitrosamine Analyser
|
|
18
|
1353
|
November 19, 2023
|
|
New data released into Lhasa Carcinogenicity Database
|
|
1
|
1005
|
November 17, 2023
|
|
Use of the TD50 99 % CI for single dose rodent carcinogenicity studies -Pub
|
|
5
|
615
|
November 16, 2023
|
|
Free Webinar: Nitrosamines in Drug Products
|
|
12
|
1876
|
November 16, 2023
|
|
Reformualtion bridging studies
|
|
3
|
636
|
November 16, 2023
|
|
Why do some mutagenic N-nitrosamines not require metabolic activation?
|
|
0
|
400
|
November 15, 2023
|
|
🇪🇺 EMA - Enhanced AMES test conditions
|
|
0
|
785
|
November 15, 2023
|
|
EMA Q&A Rev. 19 (EMA/409815/2020 Rev.19)
|
|
0
|
1734
|
November 13, 2023
|
|
Review of NDSRIs in Pharmaceutical Drugs -Pub
|
|
1
|
897
|
November 13, 2023
|
|
Revised guidance for J-CTN
|
|
3
|
397
|
November 9, 2023
|
|
AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position?
|
|
2
|
658
|
November 9, 2023
|
|
Catalysts for Nitrosamine formation?
|
|
1
|
473
|
November 7, 2023
|
|
Nitrosamine Risk Reduction In Pharmaceutical Formulations Webinar
|
|
1
|
884
|
November 6, 2023
|
|
Low nitrile crosscarmellose sodium
|
|
0
|
432
|
November 6, 2023
|
|
Does atmospheric NO2 influence the formation of NDMA in metformin?
|
|
2
|
616
|
November 3, 2023
|
|
Nitrosamine Guidance for Cream and Ophthalmic Solutions
|
|
4
|
745
|
November 3, 2023
|