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Archive

This is a library of Lhasa's blog articles. 

  • Supporting N nitrosamine risk assessments for drug products
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    Supporting N-nitrosamine risk assessments for drug products

    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.

     

    25 July 2022

  • Expert review blog
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    Is expert review an essential step when assessing mutagenic potential of drug impurities?

    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… 

    05 May 2022

  • Replace reduce refine
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    Replace, Reduce, Refine - How Lhasa Limited are supporting the 3Rs

    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.

    02 March 2022

  • Predicting N-nitrosamine carcinogenic potency using structure-activity relationships (SARs)
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    Predicting N-nitrosamine carcinogenic potency using structure-activity relationships (SARs)

    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.

    17 December 2021

  • How Derek Nexus and Sarah Nexus meet the 5 OECD principles
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    How Derek Nexus and Sarah Nexus meet the 5 OECD principles

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

    30 November 2021

  • How to make mutagenicity assessment a simpler task blog image
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    How to make mutagenicity assessment a simpler task

    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!

    15 September 2021

  • Derek Nexus Achieving high accuracy with high coverage
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    Derek Nexus – Achieving high accuracy with high coverage [an infographic]

    In this blog piece, we explore how Derek Nexus performs when evaluated against 7 different in silico skin sensitisation models.

    11 August 2021

  • 20 tips for nitrosamine impurity assessment

    20 tips for nitrosamine impurity assessment

    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!

    05 August 2021

  • Trusting expert derived knowledge; an overview of alert creation in Derek Nexus
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    Trusting expert derived knowledge; an overview of alert creation in Derek Nexus

    Derek Nexus contains alerts which predict the potential toxicity of a compound, this article explains how Lhasa scientists create alerts which are trustworthy and accurate.

    20 May 2021

  • Lhasa Limited supports the global challenge of nitrosamine impurity assessment
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    Lhasa Limited supports the global challenge of nitrosamine impurity assessment

    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.

    13 July 2020

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