Archive

Mutagenic impurities can be expected in any drug product; however, this is not a concern providing they are present below the safe limit. The objective of a carcinogenicity study is to identify compounds that can cause tumours in animals, which is imperative to understanding the cancer risk posed to humans.

N-Nitrosamine risk assessment and control have become an integral part of pharmaceutical drug product development. In this article, we discuss 3 key stages of risk assessment: identifying the source of risk, determining the level of activity and mitigating the risk. Discover how our in silico tools can be used to support informed decision making on chemical safety, in this blog article.

Would your toxicology assessments benefit from free access to long-term carcinogenicity study data? The Lhasa Carcinogenicity Database (LCDB) is a widely used, free resource of long-term carcinogenicity study data.

In this article we explore 5 things you should know about the data in the LCDB.

In this blog piece, we explore in more detail, the features of the recent release and how they will benefit LCDB users.

For many years the Carcinogenic Potency Database (CPDB)¹, created by Lois Gold and her team, was an important source of long-term carcinogenicity study data. However, as the database had stopped being updated from 2007, Lhasa moved to safeguard the data by providing ongoing access through a freely available interface; the Lhasa Carcinogenicity Database (LCDB)². The LCDB was released in 2016 and has since been updated with additional data from the National Toxicology Program (NTP)³, increasing the data set to 7,745 studies covering 1,726 chemical substances. A recent update has also facilitated greater ease of access by enabling substructure and similarity-based structure queries.

The recent discovery of N-nitrosamine (nitrosamine) impurities in several marketed pharmaceuticals has led to a requirement for further investigation into nitrosamine mutagenic and carcinogenic activity. Regulatory requirements mean that marketing authorisation holders for human medicines, containing chemically synthesised active substances, must review their medicines for the possible presence of nitrosamines and test all products at risk. Risk-based approaches to prioritise evaluations and subsequent confirmatory testing may be used. These assessments must be completed by October 2020, generating a significant challenge for the pharmaceutical industry.