N-Nitroso Betahistine formation
|
|
2
|
405
|
July 28, 2023
|
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
|
|
3
|
672
|
July 26, 2023
|
Nitrosamines and bioequivalence studies
|
|
4
|
560
|
July 20, 2023
|
Chat GPT's answer about the risk assessment of nitrosamine in pharmaceuticals
|
|
16
|
2283
|
July 3, 2023
|
Low Nitrite Excipients - it’s happening
|
|
2
|
734
|
June 30, 2023
|
Nitrosamine Risk Assessment for Drug Product Manufacturer with 50+ APIs
|
|
4
|
509
|
May 4, 2023
|
Instem SOT 2023 Presentation on Assessing N-nitrosamines Potency Classes
|
|
1
|
495
|
May 2, 2023
|
A Consideration of the Extent That Tertiary Amines Can Form N-Nitroso Dialkylamines in Pharmaceutical Products
|
|
1
|
920
|
April 25, 2023
|
NDMA formation Due to Active Ingredient Degradation and Nitrite Traces in Drug Product
|
|
0
|
625
|
March 24, 2023
|
Nitrosamines in topical products
|
|
3
|
813
|
March 9, 2023
|
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
|
|
6
|
931
|
February 25, 2023
|
Anybody has working with a Gliclazide nitrosamine?
|
|
3
|
840
|
February 14, 2023
|
IPEC Europe announces the availability of the revised “Questionnaire for Excipient Nitrosamines Risk Evaluation” (Version 4, 2022)
|
|
11
|
1147
|
February 14, 2023
|
Lhasa Tutorial Vid on new Mirabilis 4.0
|
|
2
|
419
|
January 31, 2023
|
What to do with Nitrite content reported by Excipients?
|
|
0
|
545
|
January 25, 2023
|
What's your experience on API risk assessments?
|
|
4
|
438
|
November 25, 2022
|
Checklist for EMA Q&A Q4
|
|
0
|
382
|
July 30, 2022
|
Fate purge study
|
|
0
|
314
|
July 14, 2022
|
Sufficient AMES test, parameters
|
|
6
|
852
|
July 13, 2022
|
Como conducir El Análisis de Riesgo?
|
|
0
|
276
|
May 9, 2022
|
What is the probability of nitrosamine formation during DP production
|
|
6
|
475
|
April 26, 2022
|
200+ USP Monograph w/ Tertiary amines
|
|
1
|
360
|
April 5, 2022
|
How Relevant is a 'check list'?
|
|
0
|
213
|
March 2, 2022
|
FDA Warning letter <Nitrosamine or NOT>
|
|
0
|
330
|
February 14, 2022
|
Update of the CMDh's Q&A Document on Nitrosamine Impurities
|
|
2
|
570
|
January 26, 2022
|
Nitrosamine Workshop USP / Sindusfarma / ANF ACFB -live discussion
|
|
7
|
719
|
December 8, 2021
|
When minimum information is provided for risk assessment?
|
|
1
|
231
|
November 23, 2021
|
Screening vs **Risk Assessment**?
|
|
11
|
421
|
September 7, 2021
|
Q&A Nitrosamine SAR working group (23 companies and universities)
|
|
12
|
1086
|
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
|
284
|
July 28, 2021
|