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LTL Approach for New Generic Registrations
|
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5
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464
|
October 10, 2025
|
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Nitrosamines without published AI, and possibly negative for carcinogenicity
|
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11
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1317
|
October 7, 2025
|
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Estimation of genotoxic nitroso amines impurities in empagliflozin
|
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2
|
286
|
September 15, 2025
|
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Alignment between Regulatory Agencies
|
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2
|
430
|
September 12, 2025
|
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Ask for help with limit for Nitroso-olaparib
|
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2
|
238
|
September 4, 2025
|
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N-nitroso-omadacycline mutagenic
|
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3
|
140
|
September 2, 2025
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Why EMA has done read-across for N-nitroso-desmethyl-doxylamine?
|
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9
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402
|
September 1, 2025
|
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Why do nitrosamine impurities of omacycline and tigecycline have different AI values?
|
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8
|
367
|
August 28, 2025
|
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Published limit for N-Nitroso-Vonoprazan
|
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2
|
326
|
August 15, 2025
|
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N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs
|
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15
|
4766
|
April 16, 2025
|
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Lifetime Cumulative Dose and Less Than Lifetime Approach
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3
|
592
|
July 16, 2025
|
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Criterios de aceptación
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2
|
119
|
June 26, 2025
|
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Quantifier and Qualifier Ion in mass spec
|
|
6
|
297
|
June 26, 2025
|
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Calculation of limit when more than one nitrosamine is identified
|
|
10
|
1325
|
June 19, 2025
|
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Risk (Re)Assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine Drug Substance Related Impurities
|
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2
|
242
|
June 18, 2025
|
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Using N-Nitrosodiethanolamine (NDELA) and N-Nitrosopiperidine (NPIP) Transgenic Rodent Gene Mutation Data and Quantum Mechanical Modeling to Derive Potency-Based Acceptable Intakes for NDSRIs Lacking Robust Carcinogenicity Data-Pub
|
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0
|
241
|
June 6, 2025
|
|
AI limit for 1-Nitrosopiperazine
|
|
8
|
589
|
June 4, 2025
|
|
Limits for NDMA in Dapagliflozin+Metformin
|
|
19
|
670
|
May 28, 2025
|
|
If only I had known…
|
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41
|
2283
|
May 23, 2025
|
|
How to set Acceptance criteria for nitrosamines impurities in FDC-FPPs
|
|
1
|
222
|
May 6, 2025
|
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MDD for Metformin
|
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4
|
332
|
May 2, 2025
|
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Risk Assessment ASS/Paracetamol/Coffein tablets
|
|
7
|
779
|
April 29, 2025
|
|
Visualization of Categorized Compounds by CPCA
|
|
67
|
8979
|
April 24, 2025
|
|
N-nitroso-esmolol
|
|
0
|
207
|
April 22, 2025
|
|
⁉️ Duloxetine Impurity NDSRI
|
|
9
|
1074
|
April 22, 2025
|
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The quagmire with the interim limit of nitroso duloxetine
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6
|
637
|
April 21, 2025
|
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LTL or not LTL that's the question?
|
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5
|
471
|
April 15, 2025
|
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N-Nitroso Caffeidine
|
|
3
|
174
|
April 14, 2025
|
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Risk mitigation based on DP specifications
|
|
10
|
698
|
April 7, 2025
|
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Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential -Pub
|
|
8
|
594
|
April 2, 2025
|