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Use of the less-than lifetime (LTL) concept or the use of interim limits
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|
3
|
974
|
August 1, 2023
|
|
LTL in simple terms?
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|
7
|
700
|
July 1, 2022
|
|
Maximizing use of existing carcinogenicity data to support AI levels -Pub
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|
0
|
374
|
July 31, 2023
|
|
The Nitrosamine “Saga”
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|
3
|
1625
|
July 29, 2023
|
|
Fluoxetin Recall - Austria
|
|
6
|
791
|
July 28, 2023
|
|
N-Nitroso Betahistine formation
|
|
2
|
655
|
July 28, 2023
|
|
Genotoxicity Assessment using HepaRG Models
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|
2
|
471
|
July 28, 2023
|
|
European Pharmacopoeia Commission revises position on nitrosamine impurities
|
|
2
|
629
|
July 28, 2023
|
|
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
|
|
11
|
3731
|
July 27, 2023
|
|
🇧🇷 ANVISA (Brasil) denies registration
|
|
0
|
498
|
July 27, 2023
|
|
NDSRIs: Atualizações e Desafios
|
|
0
|
471
|
July 24, 2023
|
|
N-nitroso desloratadine?
|
|
13
|
1796
|
July 22, 2023
|
|
Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations
|
|
9
|
763
|
July 21, 2023
|
|
Nitrosamines and bioequivalence studies
|
|
4
|
680
|
July 20, 2023
|
|
Forced degradation: predicting nitrosamine formation
|
|
8
|
1827
|
July 20, 2023
|
|
FDA - Notice on Chantix
|
|
3
|
627
|
July 20, 2023
|
|
How important clinically are nitrosamines?
|
|
5
|
471
|
July 19, 2023
|
|
😞 Aripiprazole is not approvable since 'major objections' have been identified
|
|
6
|
889
|
July 18, 2023
|
|
Establishment of Acceptable Intakes, framework
|
|
12
|
814
|
July 12, 2023
|
|
New Guidance from Malaysia's NPRA 03 July 2023
|
|
0
|
760
|
July 12, 2023
|
|
HELM Mexico - Seminario Nitrosaminas
|
|
4
|
599
|
July 11, 2023
|
|
🇨🇭 Swissmedic creates nitrosamine expert group to coordinate with manufacturers, regulators
|
|
2
|
551
|
July 10, 2023
|
|
What method accuracy criteria to be considered for nitrosamines, which guidance mentioned accuracy criteria?
|
|
2
|
665
|
July 10, 2023
|
|
Anybody inquired about Ramipril, Benzapril, Quinapril?
|
|
6
|
1349
|
July 10, 2023
|
|
Proposed approach to Temporary Acceptable intake Limits for NDSRIs
|
|
10
|
1371
|
July 6, 2023
|
|
Strategies for Mitigating In-Source Fragmentation in NDSRI Analysis using LC-MS
|
|
2
|
2125
|
July 3, 2023
|
|
Low Nitrite Excipients - it’s happening
|
|
2
|
982
|
June 30, 2023
|
|
🕵️ Toxicology for non-toxicologist Training?
|
|
16
|
983
|
June 27, 2023
|
|
Mitagation Strategy for NDSRIs (FDA & CRCG) Workshop
|
|
10
|
2429
|
June 23, 2023
|
|
Nitrosamines: Current Regulatory Aspects and Analytical Challenges
|
|
0
|
765
|
June 23, 2023
|