Topics tagged NDSRI

Topic	Replies	Views	Activity
Nitrosamine Impurities in Topical Drug Product Limits of Nitrosamines Manufacturing , NDSRI	3	575	February 3, 2024
Adoption of CPCA beyond FDA/ EMA Regulatory Intelligence NDSRI	9	936	January 31, 2024
🇪🇺 EMA/409815/2020 Rev.20 Guidance, Documents, Resources NDSRI	7	3889	January 31, 2024
Confidence score calculation for the carcinogenic potency categorization approach (CPCA) predictions for N-nitrosamines Limits of Nitrosamines NDSRI	5	1177	January 11, 2024
Exploring the CPCA Framework: Defining Acceptable Intake for NDSRIs -Event Events / Workshops / Webinars NDSRI	2	830	January 10, 2024
🇹🇼 Taiwan Food and Drug Administration on Nitroso - Salbutamol Confirmatory Testing & Analytical Challenges NDSRI	0	433	January 9, 2024
Reflective Beginnings: We have to be in the driver's seat Nitrosamines in the News Drug_Substance_APIs , NDSRI	4	526	January 9, 2024
N-nitroso Torasemide Impurity formation and control New Scientific Knowledge & Development Drug_Substance_APIs , NDSRI	23	1692	January 5, 2024
NDSRI in metronidazole Limits of Nitrosamines NDSRI	1	689	December 28, 2023
Redefining Nitrosamine Risks: A Fresh Perspective on Pharmaceuticals -Pub New Scientific Knowledge & Development Drug_Substance_APIs , NDSRI	16	2116	December 17, 2023
MDD for API/DP for Ophthalmic Formulation About Nitrosamines Exchange Drug_Substance_APIs , NDSRI	4	759	December 12, 2023
Control of NDSRIs impurity at Drug Substance (API) specification Limits of Nitrosamines NDSRI	8	1190	December 5, 2023
10º encontro Farmacopeia Brasileira Events / Workshops / Webinars NDSRI , Manufacturing , Drug_Substance_APIs	0	465	November 30, 2023
CPCA Calculation System (Python Desktop) Limits of Nitrosamines Limits , NDSRI	1	1201	November 22, 2023
🇨🇭 Swiss Medic Guidelines Guidance, Documents, Resources NDSRI	7	1534	November 20, 2023
🇪🇺 EMA - Enhanced AMES test conditions Guidance, Documents, Resources ames , NDSRI	0	678	November 15, 2023
Review of NDSRIs in Pharmaceutical Drugs -Pub New Scientific Knowledge & Development NDSRI	1	768	November 13, 2023
AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position? Limits of Nitrosamines Limits , FDA , NDSRI	2	573	November 9, 2023
Vilazodone Nitrosamine Confirmatory Testing & Analytical Challenges Drug_Substance_APIs , NDSRI	0	362	October 31, 2023
Review of nitrosamine drug substance related impurities (ndsri) in pharmaceutical drugs Guidance, Documents, Resources NDSRI	1	699	October 31, 2023
Personal perspective on N-Nitrosamines and recent revision of guidelines Events / Workshops / Webinars NDSRI , Excipients	7	779	October 27, 2023
Reflections on the Impact of Nitrosamine Drug Substance Related Impurities Guidance, Documents, Resources NDSRI	0	431	October 20, 2023
CPCA is now included in the updated version of Health Canada’s Guidance on nitrosamine impurities Guidance, Documents, Resources NDSRI	15	2360	October 13, 2023
NDSRIs: Analytical Challenges/ Desafios Analíticos Confirmatory Testing & Analytical Challenges NDSRI	0	578	October 11, 2023
Variation requirements Root Causes Drug_Substance_APIs , NDSRI , Storage_Stability , Excipients	2	428	October 2, 2023
关于2023药物杂质控制国际交流会的资讯 Nitrosamines in the News NDSRI	1	437	September 29, 2023
🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry Guidance, Documents, Resources NDSRI , Drug_Substance_APIs	47	6525	September 20, 2023
Nitrosamine in DS and DP specifications Limits of Nitrosamines Drug_Substance_APIs , NDSRI	2	782	September 20, 2023
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	1280	September 15, 2023
🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE Guidance, Documents, Resources NDSRI , Drug_Substance_APIs	108	21211	September 12, 2023