|
Proposed approach to Temporary Acceptable intake Limits for NDSRIs
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|
10
|
1211
|
July 6, 2023
|
|
Nitrosamines Published Limits -reference
|
|
77
|
12203
|
July 5, 2023
|
|
Limits of nitrosamine impurity below 10 ppm in drug products
|
|
0
|
642
|
June 19, 2023
|
|
Limits for N-nitroso vortioxetine
|
|
3
|
976
|
June 15, 2023
|
|
The 18 ng/day default for NDSRIs should be re-visited?
|
|
8
|
824
|
June 14, 2023
|
|
CMDh mandated the SWP/NcWP for AI derivations of N-nitrosamines
|
|
6
|
801
|
June 10, 2023
|
|
FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals
|
|
2
|
674
|
June 5, 2023
|
|
Establishing acceptable intakes (AI) for complex nitrosamines (NDSRIs)
|
|
16
|
1480
|
June 4, 2023
|
|
Fda行业指南中总亚硝胺杂质含量要求
|
|
1
|
481
|
June 2, 2023
|
|
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses
|
|
2
|
711
|
June 1, 2023
|
|
N-nitroso Des-methyl Dapoxetine
|
|
12
|
958
|
May 31, 2023
|
|
✌️Need✌️ your input on NDSRIs challenges?
|
|
33
|
2496
|
May 26, 2023
|
|
FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
|
|
1
|
1278
|
May 24, 2023
|
|
The acceptance Intake of Nitroso-Propranolol
|
|
16
|
2960
|
May 24, 2023
|
|
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines
|
|
2
|
875
|
May 23, 2023
|
|
Nitroso Furosemide
|
|
1
|
655
|
May 20, 2023
|
|
Nitrosamines in ICH S9
|
|
8
|
1070
|
May 15, 2023
|
|
AI for NDSRIs of Terbinafin hydrochloride and Impurity A
|
|
4
|
659
|
May 14, 2023
|
|
EFPIA Position paper for NDSRIs of beta-blockers and beta-agonists / ACE inhibitors / dihydropyridine
|
|
1
|
1115
|
April 24, 2023
|
|
N-Nitrosobupropion
|
|
4
|
1196
|
April 10, 2023
|
|
Theoretical 'Purge Factor'
|
|
10
|
1609
|
March 31, 2023
|
|
Unofficial/official surrogates for read-across
|
|
5
|
1624
|
March 27, 2023
|
|
Officially used surrogates for read-across method
|
|
14
|
2358
|
March 23, 2023
|
|
NDSRI complex nitrosamine Accetable Intake methodology harmonisation by regulators may be followed in Early 2024
|
|
1
|
913
|
March 14, 2023
|
|
Limit for Nitroso Atenolol
|
|
6
|
1335
|
March 14, 2023
|
|
确定DNSRI的限度需要同时进行Ames和致癌性实验吗？
|
|
4
|
507
|
March 2, 2023
|
|
A temporary AI (t-AI) of 178 ng/day (total nitrosamines) - EMA
|
|
7
|
1321
|
January 30, 2023
|
|
Nitroso-Sitagliptin Who/Where/Limit?
|
|
22
|
3932
|
January 26, 2023
|
|
Nitrosamines in solution at pH 7
|
|
4
|
639
|
January 20, 2023
|
|
Limit for Nitroso Ramipril
|
|
1
|
815
|
January 13, 2023
|