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	1792	August 22, 2022
About the Risk Assessment Strategy / Tools & Technology category	0	577	April 14, 2021
Chat GPT's answer about the risk assessment of nitrosamine in pharmaceuticals	23	2827	July 27, 2024
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies NDSRI	8	1077	July 27, 2024
TK6 Cell Line Panel	4	32	July 26, 2024
Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day	28	4611	July 26, 2024
Background on Purging Factor Calculation for your Risk Assessment	0	67	July 25, 2024
Useful publications to sharpen your skills for reviewing DS risk assessment	0	59	July 25, 2024
Call to review USP Risk Assessment Review Toolbox	110	1941	July 19, 2024
⚖️ Risk assessment not strong enough, specifically on related impurities containing secondary amine	17	1367	July 11, 2024
Risk analysis of nitrosamine impurities in liquid products (essences and flavors) Manufacturing , Excipients	3	602	June 28, 2024
A New Framework for Identifying Nitrosamine Risks	1	505	June 13, 2024
Can we bypass confirmatory testing of DP based on Theoretical Calc. of NDSRI's	6	840	June 8, 2024
Nitrosamine in Azathioprine Drug_Substance_APIs	4	757	May 14, 2024
Nitrosamines Risk in Pharmaceutical Waters	6	1194	May 8, 2024
Risk Analysis for Ergotamine Tartrate Drug_Substance_APIs	4	369	April 22, 2024
Risk Assessment Study of Nitrosamines for the API Temozolomide Industrial Process -Pub NDSRI , featured	1	1355	February 6, 2024
Application of duplex sequencing to evaluate mutagenicity -Pub NDSRI	1	299	March 14, 2024
Nitrosamines evaluation in transdermal patches	10	1634	March 5, 2024
Regulatory Highlights(OPR&D)	14	1964	February 28, 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	267	February 27, 2024
Skipping risk assessment	4	368	February 11, 2024
QSAR Toolbox - Free software. Any experience?	17	1413	January 24, 2024
Nitrosamines risk assessment and batch results	4	458	January 23, 2024
Duplex Sequencing - Future of mutagenicity assessment	3	554	January 23, 2024
Bard responds to Nitrosamine Risk Assessment scheme	1	651	January 16, 2024
Potential Event with USP & Health Authorities	8	699	February 2, 2024
QSAR Models - Ames/QSAR International Challenge Project - 21 teams from 11 countries QSAR	0	421	December 12, 2023
Nitrosamine Risk Assessment for Purified Water Used in Manufacturing for Pilot Bio/Clinical Trial Batches	2	1108	October 22, 2023
🖥 Berkeley Madonna Software for Nitrosation Kinetic Calculations	4	628	October 3, 2023

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…