Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients

In this just-released perspective for J Med Chem, Krista Dobo, Michelle Kenyon (@kenyom01), Amit Kalgutkar and I discuss the nitrosamine crisis, highlighting the importance of the metabolic activation and of evaluating the full metabolic pathways, compare the differing SAR approaches from our previous work (overlapping features in Cross and Ponting and Thomas et al vs the orthogonal categories of Dobo et al…), discuss the nitrosovarenicline case and other examples, and summarise the state-of-the-art testing paradigms! Enjoy!


Provided link is not accessible, can you please share me this document.

The paper isn’t open access, I’m afraid - it’s really expensive to make an ACS paper open access, and we’ve been rather prolific this year, so we have to direct our payments towards certain ones (e.g. Thomas et al); do you have access to a paper-buying process? If not, we may at some point be sent an author access link which I could distribute (or dm, if it’s limited use) - haven’t received this yet, though.

Please consult your organization’s knowledge management departments/library to ask for access to the publication. Another great source is your former university library.

Nitrosamine due to excipients in the drug products, can we apply NDSRI approach. Let us know thoughts on this.