Hello again it’s me Dr Candice Johnson. The E&L conference took place on May 17th – 18th and it was so nice meeting colleagues and hearing about all the developments in the E&L field. The E&L community is eagerly anticipating the changes that the ISO-10993-17 standard and the ICH Q3E guideline will bring. Several presentations …
Continue reading “Extractables and Leachables (E&L) USA 2023 Conference”
This week we are pleased to welcome Dr. Kevin Crofton and Dr. Arianna Bassan as guest contributors to the blog. Within the in silico toxicology project, a position paper on neurotoxicity is appearing in a special issue of the journal of Computational Toxicology1. This paper discusses the need for the development of more informative new …
Continue reading “Neurotoxicity hazard assessment framework that integrates in silico approaches”
The ability to predict organ toxicity directly from a chemical structure would support many applications throughout the product life cycle, from screening candidates to formulating testing strategies and assessing non-genotoxic impurities. A recent cross-industry working group, as part of the in silico toxicology protocol project1, was initiated to understand the needs and challenges for in …
Leadscope, Inc. (an Instem company), in collaboration with Lhasa Limited are leading a working group of pharmaceutical toxicologists and consultants investigating the carcinogenic potency and structure-activity relationships of N-nitrosamines. This is in response to the recent discovery of N-nitrosamines in marketed pharmaceuticals and the regulatory changes that have resulted. The working group is run by …
Nitrosamine impurities currently belong to a “cohort of concern” because of their potential to be potent mutagenic carcinogens, as described in the ICH M7 guideline1. They are also coming under increasing regulatory scrutiny with the US Food and Drug Administration and European Medicines Agency recently issuing new guidelines2,3 for examination of this class. These guidelines …
Continue reading “Establishing potency categories for Nitrosamine impurities”
