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FDA/HESI Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs workshop

We were pleased to attend the FDA/HESI Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs workshop. Organised by the FDA and HESI, this exciting event offered attendees the opportunity to engage in important discussions around the assessment of nitrosamines, including Nitrosamine Drug Substance-related Impurities (NDSRI). Lhasa Principal Scientist, David Ponting presented […]

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Nonclinical Carcinogenicity Studies: Fundamentals, Case Studies and Regulatory Trends

Dr. Susanne Stalford, Lhasa Principal Scientist, presented within a Pharmaceutical & BioScience Society workshop, on the topic of Nonclinical Carcinogenicity Studies. The workshop included presentations from regulatory and industry perspectives, on topics relating to carcinogenicity assessment of pharmaceuticals, including: The challenges faced with carcinogenicity assessments, in the development of pharmaceuticals Regulatory and industry perspectives on

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Extractables & Leachables USA

We thoroughly enjoyed attending Extractables and Leachables USA! This event offered a unique opportunity for E&L industry experts to gather and discuss the latest updates on regulations, best practices, compliance, case studies, biocompatibility, and more. Lhasa Application Scientist, Charlie Modlin presented “Using expert knowledge and machine learning to assess the mutagenicity and skin sensitisation potential

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