Risk Assessment Strategy / Tools & Technology

Topic	Replies	Views	Activity
Carcinogenic Potency Database - Access free With discussions about limits and how they are establish, it’s an important reminder about the Carcinogenic Potency Database, now The Lhasa Carcinogenicity Database (LCDB). Below from Lhasa article: “5 things you should…	3	2374	August 22, 2022
About the Risk Assessment Strategy / Tools & Technology category	0	644	April 14, 2021
Nitrosamine Purge Factor Calculation Drug_Substance_APIs	1	343	December 30, 2025
The Impact of API Synthesis Optimization on Reducing Nitrosamine Risk: A Technical Walkthrough risk-assessment	0	204	December 20, 2025
Chat GPT's answer about the risk assessment of nitrosamine in pharmaceuticals	32	3771	October 13, 2025
⚖️ Risk assessment not strong enough, specifically on related impurities containing secondary amine	24	2359	September 25, 2025
Stability in risk assessment report risk-assessment	12	510	September 10, 2025
Call to review USP Risk Assessment Review Toolbox	125	3599	August 20, 2025
Background on Purging Factor Calculation for your Risk Assessment featured , purge	7	1343	August 13, 2025
Nitrosamine Risk Mitigation Calculator (by DFE Pharma) NDSRI , featured	1	1072	August 11, 2025
Nitrosamines evaluation in transdermal patches	12	2060	July 16, 2025
Excipient Nitrosamine Risk Assessment Tool	0	342	June 30, 2025
CMO Nitrosamine Risk Assessment Drug_Substance_APIs , NDSRI , risk-assessment	7	477	June 27, 2025
How to decide if one anticancer drug is for advanced cancer? risk-assessment	12	676	June 13, 2025
📖 Drug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in Medicines-Pub risk-assessment , featured	2	822	May 27, 2025
Can we bypass confirmatory testing of DP based on Theoretical Calc. of NDSRI's	9	1485	April 24, 2025
Nitrosamines in topical products	4	1247	April 15, 2025
NDSRI in finishe products risk-assessment	2	402	March 13, 2025
N-nitrosoamides - a horse of a different color Drug_Substance_APIs	54	7172	March 6, 2025
Risk Assessment and Management Strategy of Two New Nitrosamine Drug Substance Related Impurities (NDSRIs) in a Pharmaceutical Drug Product for the Treatment of a Rare Disease- from Prediction to Control-Pub NDSRI	0	567	January 29, 2025
📽 Introduction to Using (Q)SAR for the Assessment of Potential Mutagenicity of Drug Impurities QSAR	0	261	October 30, 2024
🖥 Berkeley Madonna Software for Nitrosation Kinetic Calculations	5	813	October 10, 2024
QSAR Toolbox - Free software. Any experience?	18	2064	September 4, 2024
Anybody inquired about Nitrosamines in Poly bags? Packaging	8	1681	August 29, 2024
How much Amine and Nitrating agent "Stoichiometric Ratio" required for formation of Nitrosamine impurities? Drug_Substance_APIs , NDSRI	3	315	August 28, 2024
Regulatory Highlights(OPR&D)	15	2223	August 21, 2024
Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day	29	6627	August 19, 2024
TK6 Cell Line Panel	5	229	July 29, 2024
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies NDSRI	8	1460	July 27, 2024
Useful publications to sharpen your skills for reviewing DS risk assessment	0	349	July 25, 2024

Carcinogenic Potency Database - Access free

With discussions about limits and how they are establish, it’s an important reminder about the Carcinogenic Potency Database, now The Lhasa Carcinogenicity Database (LCDB). Below from Lhasa article: “5 things you should…