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	2095	August 22, 2022
About the Risk Assessment Strategy / Tools & Technology category	0	618	April 14, 2021
Chat GPT's answer about the risk assessment of nitrosamine in pharmaceuticals	27	3168	January 11, 2025
Call to review USP Risk Assessment Review Toolbox	114	2600	December 26, 2024
N-nitrosoamides - a horse of a different color Drug_Substance_APIs	47	5346	December 18, 2024
⚖️ Risk assessment not strong enough, specifically on related impurities containing secondary amine	20	1923	November 28, 2024
How to decide if one anticancer drug is for advanced cancer? risk-assessment	8	388	November 20, 2024
📽 Introduction to Using (Q)SAR for the Assessment of Potential Mutagenicity of Drug Impurities QSAR	0	203	October 30, 2024
🖥 Berkeley Madonna Software for Nitrosation Kinetic Calculations	5	751	October 10, 2024
QSAR Toolbox - Free software. Any experience?	18	1725	September 4, 2024
Anybody inquired about Nitrosamines in Poly bags? Packaging	8	1527	August 29, 2024
How much Amine and Nitrating agent "Stoichiometric Ratio" required for formation of Nitrosamine impurities? Drug_Substance_APIs , NDSRI	3	196	August 28, 2024
Regulatory Highlights(OPR&D)	15	2193	August 21, 2024
Can we bypass confirmatory testing of DP based on Theoretical Calc. of NDSRI's	8	1181	August 20, 2024
Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day	29	5812	August 19, 2024
TK6 Cell Line Panel	5	161	July 29, 2024
Background on Purging Factor Calculation for your Risk Assessment	1	406	July 29, 2024
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies NDSRI	8	1363	July 27, 2024
Useful publications to sharpen your skills for reviewing DS risk assessment	0	304	July 25, 2024
Risk analysis of nitrosamine impurities in liquid products (essences and flavors) Manufacturing , Excipients	3	724	June 28, 2024
A New Framework for Identifying Nitrosamine Risks	1	614	June 13, 2024
Nitrosamine in Azathioprine Drug_Substance_APIs	4	845	May 14, 2024
Nitrosamines Risk in Pharmaceutical Waters	6	2021	May 8, 2024
Risk Analysis for Ergotamine Tartrate Drug_Substance_APIs	4	417	April 22, 2024
Risk Assessment Study of Nitrosamines for the API Temozolomide Industrial Process -Pub NDSRI	1	2047	February 6, 2024
Application of duplex sequencing to evaluate mutagenicity -Pub NDSRI	1	357	March 14, 2024
Nitrosamines evaluation in transdermal patches	10	1804	March 5, 2024
Is it possible to observe N-nitrosamines formation from oximes? Do you have any reference to support the risk assessment for nitrosamine formation from the reaction of these functional groups in the presence of nitrosating agents? Thank you NDSRI	2	304	February 27, 2024
Skipping risk assessment	4	438	February 11, 2024
Nitrosamines risk assessment and batch results	4	576	January 23, 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…