Archive

In November last year, we published a ground-breaking article to Chemical Research in Toxicology titled ‘What Makes a Potent Nitrosamine? Statistical Validation of Expert-Derived Structure–Activity Relationships’.  

Within the paper, we show that certain structural features, when treated independently, have a statistically significant impact on the carcinogenic potency of nitrosamines. It is with great excitement that we share this publication making it to Chemical Research in Toxicology’s top 20 most downloaded articles, as well as being the most viewed article within their November edition. 

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.

I recently read that by 2025, 36% of world data will be healthcare data. (Yes, thirty-six percent!). Considering this statistic, now more than ever, it is important that we are working to ensure existing data is utilised to make better safety assessment decisions more quickly - whilst also relying less on animal testing.

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.

A provision for the application of ‘expert knowledge’ is mentioned within the ICH M7 guideline. However, as (Q)SAR models continue to be updated and their predictive performance and structural coverage improves, this raises the question of whether expert review is still necessary… 

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. As a result, there is a need to assess the risk posed by mutagenic impurities.
To discuss this topic in more detail, we were delighted to welcome Andrew Teasdale PhD and Muzaffar Khan PhD, to present at our webinar; Controlling potentially mutagenic impurities - hear from industry experts!

In case you missed this event, we have summarised the top eight take away tips from the webinar, for quick and easy consumption within this article. 

Last year, a revolutionary guideline on Defined Approaches for Skin Sensitisation (OECD GL No.497) was released by the OECD. It is the first ever guideline that recommends the use of a combination of non-animal methods to predict whether a chemical can cause skin allergies. Since the publication of this guideline, Lhasa Limited have developed ‘Skin Sensitisation Defined Approach ITSv1 1.0’ – a web application containing one of the defined approaches published by the OECD, which provides hazard and potency skin sensitisation predictions without the use of animal tests. This tool is a step towards full replacement of animal testing for skin sensitisation and employs the 3Rs principle.

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.

This blog article introduces an insightful publication by Lhasa Principal Scientist, Dr. David Ponting and Dr. Kevin Cross from Instem, which investigates whether improvements in structure-activity relationships can more accurately predict N-nitrosamine carcinogenic potency.