Topics tagged NDSRI

Topic	Replies	Views	Activity
👨‍💻 Dashboard Containing Published AI Limits Guidance, Documents, Resources featured , NDSRI , AI Are you looking for a central place for published AI limits? I have created a dashboard containing Acceptable Intake Limits from FDA, Health Canada and EMA. I am looking for folks that are interest into contributing to …	25	2244	July 24, 2024
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies Risk Assessment Strategy / Tools & Technology NDSRI	8	1076	July 27, 2024
How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits New Scientific Knowledge & Development NDSRI	0	15	July 26, 2024
🛑 N-nitroso Ticagrelor N-nitrosamines Chemistry NDSRI	11	2006	July 26, 2024
Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines Nitrosamines in the News FDA , NDSRI	5	1058	July 20, 2024
USP - CPCA Nitrosamines Case Study Guidance, Documents, Resources NDSRI	5	953	July 10, 2024
🇨🇦 Health Canada updated the guidance and Appendix 1(May 31, 2024) Limits of Nitrosamines NDSRI	16	1518	July 10, 2024
Control limit of Nitrosamines and N-nitroso compounds Limits of Nitrosamines Manufacturing , risk-assessment , Drug_Substance_APIs , NDSRI	2	285	July 8, 2024
AI for NDSRI by Brazil regulatory Guidance, Documents, Resources NDSRI	4	551	June 28, 2024
Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity? Guidance, Documents, Resources Drug_Substance_APIs , NDSRI	6	297	June 27, 2024
Discussion on Cleaning Validation Requirements for Nitrosamines New Scientific Knowledge & Development Manufacturing , NDSRI	3	694	June 24, 2024
Tetrazole nitrosamines Limits of Nitrosamines Drug_Substance_APIs , NDSRI	1	206	June 13, 2024
Quelles Nitrosamines la Picloxidine est-elle susceptible de former? N-nitrosamines Chemistry NDSRI	1	248	June 12, 2024
Limit for API having two NDSRI Limits of Nitrosamines NDSRI	14	1907	June 11, 2024
Examining the Use of Surrogates in Combination with The Carcinogenic Potency Categorization Approach when Establishing Acceptable Intake Limits of N-Nitrosamine Impurities Limits of Nitrosamines NDSRI	0	399	June 9, 2024
Structuring expert review using AOPs: Enabling robust weight-of-evidence assessments for carcinogenicity under ICH S1B(R1) Limits of Nitrosamines NDSRI	0	233	June 9, 2024
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation New Scientific Knowledge & Development NDSRI , featured	16	2633	June 8, 2024
Update: EFPIA workflows for Quality Risk management Jun 2024 v03 Guidance, Documents, Resources Packaging , Manufacturing , Drug_Substance_APIs , Excipients , NDSRI	2	384	June 4, 2024
🇨🇦 Health Canada updated the guidance and Appendix 1(March 15, 2024) Limits of Nitrosamines NDSRI	11	2572	June 3, 2024
Visualization of Categorized Compounds by CPCA Limits of Nitrosamines NDSRI	64	7624	June 1, 2024
🇺🇸 FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop Events / Workshops / Webinars NDSRI	32	1757	June 1, 2024
N-nitroso-nitrofurantoin N-nitrosamines Chemistry NDSRI	0	188	May 31, 2024
⚙️🌎CPCA: the gestation, birth, and development -Pub New Scientific Knowledge & Development NDSRI	5	1042	May 31, 2024
Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs Events / Workshops / Webinars Live-Conversations , NDSRI , Drug_Substance_APIs , Manufacturing , Excipients	21	1356	May 22, 2024
Category 5 NDSRIs- CPCA tool Limits of Nitrosamines Drug_Substance_APIs , NDSRI	2	385	May 20, 2024
Challenges and winning strategies to develop an analytical method for Nitrosamines Confirmatory Testing & Analytical Challenges NDSRI	0	572	May 19, 2024
Hot of the presses - New CPCA paper Limits of Nitrosamines NDSRI	1	360	May 17, 2024
Nitrosamine and NDSRIs conventional detection methods and other options Confirmatory Testing & Analytical Challenges NDSRI	5	280	May 16, 2024
Managing the complexities of NDSRI method development: The N-nitroso propranolol case story Events / Workshops / Webinars NDSRI	0	469	May 14, 2024
How to justify the absence of NDSRIs in finished product if the custom synthesis of the same NDSRIs is not possible? Confirmatory Testing & Analytical Challenges NDSRI	1	560	May 13, 2024

👨‍💻 Dashboard Containing Published AI Limits

Are you looking for a central place for published AI limits? I have created a dashboard containing Acceptable Intake Limits from FDA, Health Canada and EMA. I am looking for folks that are interest into contributing to …