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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.

In this article, we discuss how Derek Nexus and Sarah Nexus meet the 5 OECD principles.

“As Adverse Outcome Pathways (AOPs) move from being an interesting scientific concept, to a useful practical application tool, this is an exciting time for both industry and Lhasa” … Regular Lhasa blog readers will have read this statement within our September blog “Shaping Lhasa Limited’s scientific direction through collaboration”.

It is with great excitement that this month we can provide you with another pioneering update on the topic of our AOP work; Our paper, “Employing an adverse outcome pathway framework for weight-of-evidence assessment with application to the ICH S1B guidance addendum” has now been published in the Regulatory Toxicology and Pharmacology Journal!

A key requirement of ICH M7 is to use two complementary (Q)SAR methodologies, one expert rule-based and the second statistical-based. This blog article recognises the benefits provided when in silico systems are integrated to provide a full ICH M7 assessment in one environment.

Discover how Lhasa Limited can help make mutagenicity assessment a simpler task, in this article!

“Our technology is designed by scientists, for scientists, in collaboration with industry stakeholders and regulators” …

At Lhasa Limited we often talk about the importance of industry and regulatory input in shaping our scientific direction. This article discusses a few key areas of involvement and collaboration plus, focuses on a recent example, on the topic of Adverse Outcome Pathways (AOPs). Read on to learn more and find out how you can get involved!

Many readers will be aware of the risk posed by nitrosamine impurities, as an ongoing pharmaceutical industry hot topic. In July 2021 ANVISA published their guidance for assessment and control of potentially carcinogenic nitrosamines in active pharmaceutical ingredients and drug products. To discuss this topic, we invited knowledgeable speakers from ANVISA, Industry - GSK and Libbs Farmacêutica - and Lhasa to give their perspectives on this topic. This article details the top 20 take away points from the workshop for quick and easy consumption - enjoy!