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 …
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 …
What does the EMA update on nitrosamine impurities mean for you? Read More »
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 …
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 …
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 …
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 …
Animal-Free Safety Assessment (AFSA) Masterclass launched Read More »
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 …
Establishing best practice for impurity purge by solubility Read More »
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. ICH M7 in practice The …
How to calculate the safe limit for carcinogens as per ICH M7 Read More »
Evaluating the potential toxicity of chemicals is an important part of the drug development process. Optimizing a data set that provides quality over quantity is critical in the search for suitable drug candidates. Developed by our scientists, Vitic is a chemical database and information management system that provides rapid access to high-quality toxicity data from …
Ensuring data quality in Vitic; three benchmarks for data quality success Read More »
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. Within many sectors …
Using existing data better and relying less on animal testing Read More »
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