Author name: lhasalimited

The nitrosamine crisis first erupted in July 2018, when the FDA announced voluntary recall of several drugs containing Valsartan: a medicine used to treat high blood pressure and heart failure. Due to an unreported change in synthesis of Valsartan, the potentially cancer-causing chemical N-nitrosodimethylamine (or NDMA) was detected in the marketed drug product. This resulted […]

With technical input from Andrew Thresher. 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. 1. The Lhasa Carcinogenicity

When assessing the mutagenic potential of drug impurities in silico, the ICH M7 guideline states that two complementary (Q)SAR prediction methodologies should be applied. A provision for the application of ‘expert knowledge’ is also mentioned within the guideline. However, as (Q)SAR models continue to be updated and their predictive performance and structural coverage improves, this raises

Article written by Ally Reeves with top tips provided by Sara Atkinson. A key consideration within drug substance synthesis is the potential presence of mutagenic impurities. Potentially mutagenic impurities (PMIs) often arise from reagents which are essential for the synthesis of a final active pharmaceutical ingredient (API) meaning that the risk is therefore often unavoidable.

The three words “replace“, “reduce” and “refine” provide an indispensable framework for performing more humane animal research. Also know as the 3Rs, the principle aims to limit the number of animals used in experiments, replace animal tests with alternatives and minimise the distress placed on animals. Last year, a revolutionary guideline on Defined Approaches for

Nitrite analysis of excipients is a new and analytically challenging area, with many organisations working quickly to determine the best practice and techniques to use. The Nitrites in Excipients data sharing consortium was established in September 2020 and is part of Lhasa Limited’s effort to support the global challenge of nitrosamine risk assessment. Currently the

As a result of high carcinogenic potency of several N-nitrosamines in rodents, regulatory agencies are now requiring N-nitrosamine risk assessments to be performed on all marketed medical products. The EMA, U.S. FDA and other regulatory agencies have set acceptable daily intake (ADI) limits for some N-nitrosamines. These values are calculated from rodent carcinogenicity TD50 values for

Are you aware of the 5 OECD principles, which validate (Q)SAR models for their use in regulatory assessment of chemical safety? The Joint Research Centre (JRC) have established a harmonised template known as the QSAR Model Reporting Format (QMRF), which can be used to summarise key information on (Q)SAR models, including results of any validation