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Innovate

Discover the latest innovations in computer-aided reasoning and information systems.

NIHS collaboration: revolutionising chemical safety assessment and reducing animal testing reliance.

NIHS collaboration: revolutionising chemical safety assessment and reducing animal testing reliance

Have you read our collaborative paper, published with the National Institute of Health Sciences (NIHS) of Japan? The paper is based on our shared project to improve in silico developmental and reproductive toxicity (DART) predictions, to safely move towards replacing traditional animal testing for chemical safety assessments. “The outcome of this collaborative and innovation project

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How well do you know your synthetic process?

Unreported changes to synthetic processes lead to the surprise presence of nitrosamine impurities in marketed drug products. This discovery resulted in the recall of several hypertension, heartburn, and diabetes medications. The nitrosamines crisis While many impurities are introduced directly as reagents, potentially mutagenic impurities (PMIs) arising during manufacture can be harder to identify as they

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nitrosamine impurity risk assessment

What does the EMA update on nitrosamine impurities mean for you?

Revised guidance released by the European Medicines Agency (EMA) on 7th July sparked excitement within the scientific community. By unveiling a new system to classify nitrosamines, EMA demonstrates that regulators are supporting industry in solving the complex problem of nitrosamine impurity assessment. The new approach will benefit industry, regulators and ultimately patients. What exactly are the

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The future of dermatological safety: FDA’s new approach to predicting dermal sensitisation

Traditional methods for evaluating the immunotoxic potential of pharmaceuticals typically involve animal testing, which is time-consuming, costly, and raises ethical concerns. In response to these challenges, regulatory agencies, including the Food and Drug Administration (FDA), are actively encouraging the development and acceptance of alternative methods. FDA’s new guidance on dermal sensitisation The FDA has recently

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Veterinary medicines blog

Harnessing (Q)SAR models to control mutagenic impurities in veterinary medicinal products

Veterinary medicines are commonly used by veterinarians, farmers and pet owners to treat and prevent animal diseases. Like what is already in place for pharmaceutical products within ICH M7, a guideline is also available for veterinary medicinal products to ensure appropriate control of mutagenic impurities. The guideline provides a practical framework that is applicable to

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The best of both worlds: combining a defined approach and read-across to predict skin sensitisation potency

New approach methodologies (NAMs) are non-animal methods – including in chemico/in vitro assays and in silico predictions – which are increasingly being used to assess the safety of cosmetic ingredients and products. A next generation risk assessment (NGRA) framework for skin sensitisation has recently been developed, and case studies highlighting the role of NAMs, defined

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Animal-Free Safety Assessment (AFSA) Masterclass launched

We are delighted to announce our participation in the Animal-Free Safety Assessment for Cosmetics (AFSA) Masterclass. Launched in March 2023, this free, online training programme is designed to build capacity and confidence in animal-free safety assessment of cosmetics and ingredients. Over the last three years, our scientists have helped to build a one-of-a-kind educational course

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Establishing best practice for impurity purge by solubility

Establishing best practice for impurity purge by solubility

We are delighted to share our vital new article ‘Establishing best practice for the application and support of solubility purge factors’ which was recently published in Organic Process Research & Development (OPRD). The paper has been written by Lhasa Principal Scientist Michael Burns, alongside industry expert co-authors from AstraZeneca, GSK, Hoffman LaRoche and other forward

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