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Update: EFPIA workflows for Quality Risk management Jun 2024 v03
|
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2
|
962
|
June 4, 2024
|
|
AI limit of API having very law MDD
|
|
1
|
350
|
May 27, 2024
|
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Category 5 NDSRIs- CPCA tool
|
|
2
|
525
|
May 20, 2024
|
|
Nitrosamine in Azathioprine
|
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4
|
870
|
May 14, 2024
|
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APIC NA Risk Assessment Template
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5
|
3654
|
May 11, 2024
|
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Risk Analysis for Ergotamine Tartrate
|
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4
|
437
|
April 22, 2024
|
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Nitrosamines: A new systematic review
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|
8
|
3204
|
April 13, 2024
|
|
AI Limit for Nitroso Nebivolol
|
|
11
|
2765
|
April 3, 2024
|
|
AI difference between FDA and EMA, HC and TGA
|
|
0
|
1168
|
March 22, 2024
|
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Nitroso amines quantification in drugs which are having MDD Value more than 10.0g/Day
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|
2
|
441
|
March 20, 2024
|
|
New Validated LC-MS Method Development and Estimation of Nitrosamine impurities in Canaglifozin -Pub
|
|
0
|
801
|
February 16, 2024
|
|
N- nitroso Nitazoxanide
|
|
1
|
533
|
February 8, 2024
|
|
Reflective Beginnings: We have to be in the driver's seat
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4
|
559
|
January 9, 2024
|
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Redefining Nitrosamine Risks: A Fresh Perspective on Pharmaceuticals -Pub
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16
|
2475
|
December 17, 2023
|
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Quantification of 13 N-Nitrosamines in Pharmaceuticals using SPE-LC-MS/MS
|
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0
|
957
|
December 13, 2023
|
|
MDD for API/DP for Ophthalmic Formulation
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4
|
1026
|
December 12, 2023
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10º encontro Farmacopeia Brasileira
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0
|
521
|
November 30, 2023
|
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Does atmospheric NO2 influence the formation of NDMA in metformin?
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2
|
617
|
November 3, 2023
|
|
Vilazodone Nitrosamine
|
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0
|
453
|
October 31, 2023
|
|
Lumateperone tosylate NDSRI impurity
|
|
1
|
890
|
October 6, 2023
|
|
Variation requirements
|
|
2
|
449
|
October 2, 2023
|
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🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry
|
|
47
|
7285
|
September 20, 2023
|
|
Nitrosamine in DS and DP specifications
|
|
2
|
858
|
September 20, 2023
|
|
Apixaban Drug Substance-Related Impurities (NDSRIs)
|
|
3
|
1536
|
September 15, 2023
|
|
Nitrite Detection at Picogram Level, is it possible?
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4
|
1102
|
September 14, 2023
|
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🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE
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|
108
|
24803
|
September 12, 2023
|
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Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients
|
|
4
|
678
|
August 23, 2023
|
|
Nitrosaminas: Estrutura química vs Potencial carcinogênico
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|
3
|
583
|
August 23, 2023
|
|
Total impurities limit if more than one nitrosamine impurities are observed in product
|
|
4
|
684
|
August 14, 2023
|
|
Planilha CPCA na prática
|
|
0
|
475
|
August 6, 2023
|