New Scientific Knowledge & Development

Topic	Replies	Views	Activity
How to avoid NDMA in Metformin? (In press) Back in October 2020, we saw an increased concern about the potential presence of NDMA in Metformin. @trust_user_a @trust_user_b @trust_user_c “As of October 2020, EMA and the national competent authorities are asking …	3	1057	August 22, 2022
About the New Scientific Knowledge & Development category	0	377	April 14, 2021
How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits NDSRI	0	15	July 26, 2024
Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub	1	50	July 26, 2024
Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies -Pub ICH-M7	0	197	July 23, 2024
🙋‍♂️ Citizen Petition to FDA on Sitagliptin	27	3195	July 20, 2024
🇯🇵 Current Nitrosamine Landscape in Japan?	103	9557	July 20, 2024
Quantum Mechanical Assessment of Nitrosamine Potency	3	337	July 15, 2024
AZIDO Impurities Topic	4	1082	July 11, 2024
A Case to Support the Continued Use of Rifampin in Clinical Drug–Drug Interaction Studies -Pub rifampin	0	126	July 10, 2024
Non-mutagenic, carcinogenic impurities Drug_Substance_APIs , ICH-M7	3	389	June 30, 2024
Discussion on Cleaning Validation Requirements for Nitrosamines Manufacturing , NDSRI	3	694	June 24, 2024
On the role of digital tools in nitrosamine risk assessment for drug substance and drug product manufacturing processes -Pub risk-assessment	0	141	June 13, 2024
EMA-funded project to predict in-vivo mutagenicity / mutagenicity classification	9	933	June 11, 2024
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	16	2633	June 8, 2024
A new root cause? NOx	13	1584	November 17, 2023
Formaldehyde Catalysis of Nitrosamine Formation	3	521	May 31, 2024
⚙️🌎CPCA: the gestation, birth, and development -Pub NDSRI	5	1042	May 31, 2024
Genotoxicity assessments of N-nitrosoethylisopropylamine (NEIPA) and N-nitrosodiisopropylamine (NDIPA) in the C57BL/6J mouse -Pub NEIPA , NDIPA	0	236	May 13, 2024
Are nitrosamines the connecting link or one of the connecting links between the concepts of phototoxicity and photocarcinogenicity due to the intake of a contaminated medication according to the 2019/ 2023 FDA list?	41	1125	May 11, 2024
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub	9	922	May 10, 2024
Clinico-pathological correlations after intake of potentially nitrosamine/ NDSRIs contaminated drugs NDSRI	1	261	April 14, 2024
Nitrosamines: A new systematic review Drug_Substance_APIs , NDSRI	11	2774	April 14, 2024
SOT posters and talks, (shared posters -update)	3	691	April 10, 2024
1st release of Lhasa 'Complex Nitrosamines' data sharing initiative	6	1030	March 31, 2024
Antioxidant as a risk mitigation strategy NDSRI	5	609	March 28, 2024
Acceptable Intakes (AIs) for 11 Small molecule N-nitrosamines (NAs) -Pub	17	2473	March 28, 2024
Lack of effect of antioxidants on Biopharmaceutics Classification System (BCS) Class III drug permeability -Pub Excipients	1	443	March 13, 2024
Role of Carbonyl Compounds for N-Nitrosamine Formation during Nitrosation: Kinetics and Mechanisms	0	357	March 2, 2024
In Silico Prediction of Pharmaceutical Degradation Pathways: A Benchmarking Study Using the Software Program Zeneth NDSRI	3	350	February 24, 2024

How to avoid NDMA in Metformin? (In press)

Back in October 2020, we saw an increased concern about the potential presence of NDMA in Metformin. @trust_user_a @trust_user_b @trust_user_c “As of October 2020, EMA and the national competent authorities are asking …