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	2182	August 22, 2022
About the Risk Assessment Strategy / Tools & Technology category	0	630	April 14, 2021
Nitrosamines in topical products	4	1136	April 15, 2025
NDSRI in finishe products risk-assessment	2	270	March 13, 2025
N-nitrosoamides - a horse of a different color Drug_Substance_APIs	54	6248	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	439	January 29, 2025
Chat GPT's answer about the risk assessment of nitrosamine in pharmaceuticals	27	3298	January 11, 2025
Call to review USP Risk Assessment Review Toolbox	114	2695	December 26, 2024
⚖️ Risk assessment not strong enough, specifically on related impurities containing secondary amine	20	1985	November 28, 2024
How to decide if one anticancer drug is for advanced cancer? risk-assessment	8	415	November 20, 2024
📽 Introduction to Using (Q)SAR for the Assessment of Potential Mutagenicity of Drug Impurities QSAR	0	232	October 30, 2024
🖥 Berkeley Madonna Software for Nitrosation Kinetic Calculations	5	769	October 10, 2024
QSAR Toolbox - Free software. Any experience?	18	1844	September 4, 2024
Anybody inquired about Nitrosamines in Poly bags? Packaging	8	1583	August 29, 2024
How much Amine and Nitrating agent "Stoichiometric Ratio" required for formation of Nitrosamine impurities? Drug_Substance_APIs , NDSRI	3	224	August 28, 2024
Regulatory Highlights(OPR&D)	15	2201	August 21, 2024
Can we bypass confirmatory testing of DP based on Theoretical Calc. of NDSRI's	8	1235	August 20, 2024
Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day	29	6072	August 19, 2024
TK6 Cell Line Panel	5	172	July 29, 2024
Background on Purging Factor Calculation for your Risk Assessment	1	540	July 29, 2024
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies NDSRI	8	1389	July 27, 2024
Useful publications to sharpen your skills for reviewing DS risk assessment	0	324	July 25, 2024
Risk analysis of nitrosamine impurities in liquid products (essences and flavors) Manufacturing , Excipients	3	739	June 28, 2024
A New Framework for Identifying Nitrosamine Risks	1	645	June 13, 2024
Nitrosamine in Azathioprine Drug_Substance_APIs	4	860	May 14, 2024
Nitrosamines Risk in Pharmaceutical Waters	6	2482	May 8, 2024
Risk Analysis for Ergotamine Tartrate Drug_Substance_APIs	4	435	April 22, 2024
Risk Assessment Study of Nitrosamines for the API Temozolomide Industrial Process -Pub NDSRI	1	2051	February 6, 2024
Application of duplex sequencing to evaluate mutagenicity -Pub NDSRI	1	367	March 14, 2024
Nitrosamines evaluation in transdermal patches	10	1846	March 5, 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…