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Risk Assessemento of Nitrosamines in soft capsule
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6
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1587
|
August 16, 2023
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On the Risk of Nitrosamine Contamination during blister packaging
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2
|
1167
|
August 10, 2023
|
|
N-Nitroso Betahistine formation
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2
|
724
|
July 28, 2023
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Nitrosamines and bioequivalence studies
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4
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744
|
July 20, 2023
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Low Nitrite Excipients - it’s happening
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2
|
1040
|
June 30, 2023
|
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Nitrosamine Risk Assessment for Drug Product Manufacturer with 50+ APIs
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4
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754
|
May 4, 2023
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Instem SOT 2023 Presentation on Assessing N-nitrosamines Potency Classes
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1
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698
|
May 2, 2023
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A Consideration of the Extent That Tertiary Amines Can Form N-Nitroso Dialkylamines in Pharmaceutical Products
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1
|
1368
|
April 25, 2023
|
|
NDMA formation Due to Active Ingredient Degradation and Nitrite Traces in Drug Product
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0
|
785
|
March 24, 2023
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Formation of Dialkyl-N-nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation
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6
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1482
|
February 25, 2023
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|
Anybody has working with a Gliclazide nitrosamine?
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3
|
1267
|
February 14, 2023
|
|
IPEC Europe announces the availability of the revised “Questionnaire for Excipient Nitrosamines Risk Evaluation” (Version 4, 2022)
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11
|
1907
|
February 14, 2023
|
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Lhasa Tutorial Vid on new Mirabilis 4.0
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2
|
607
|
January 31, 2023
|
|
What to do with Nitrite content reported by Excipients?
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0
|
684
|
January 25, 2023
|
|
What's your experience on API risk assessments?
|
|
4
|
690
|
November 25, 2022
|
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Checklist for EMA Q&A Q4
|
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0
|
538
|
July 30, 2022
|
|
Fate purge study
|
|
0
|
433
|
July 14, 2022
|
|
Sufficient AMES test, parameters
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6
|
1433
|
July 13, 2022
|
|
Como conducir El Análisis de Riesgo?
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0
|
401
|
May 9, 2022
|
|
What is the probability of nitrosamine formation during DP production
|
|
6
|
716
|
April 26, 2022
|
|
200+ USP Monograph w/ Tertiary amines
|
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1
|
508
|
April 5, 2022
|
|
How Relevant is a 'check list'?
|
|
0
|
342
|
March 2, 2022
|
|
FDA Warning letter <Nitrosamine or NOT>
|
|
0
|
492
|
February 14, 2022
|
|
Update of the CMDh's Q&A Document on Nitrosamine Impurities
|
|
2
|
978
|
January 26, 2022
|
|
Nitrosamine Workshop USP / Sindusfarma / ANF ACFB -live discussion
|
|
7
|
1109
|
December 8, 2021
|
|
When minimum information is provided for risk assessment?
|
|
1
|
344
|
November 23, 2021
|
|
Screening vs **Risk Assessment**?
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|
11
|
751
|
September 7, 2021
|
|
Q&A Nitrosamine SAR working group (23 companies and universities)
|
|
12
|
1583
|
August 25, 2021
|
|
What steps is FDA taking or planing to take, to collaborate with other regulatory authorities to align on expectations for Step 2 confirmatory testing?
|
|
4
|
388
|
July 28, 2021
|
|
Determining structural similarity for read-across
|
|
2
|
405
|
July 8, 2021
|