Archive

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.