How to establish acceptable intake limits for NDSRIs (in Japanese)

Our webinar ‘How to establish acceptable intake limits for NDSRIs’ was hosted in Japanese and contains pre-recorded videos with Japanese subtitles. This virtual event lasted approximately 2 hours. Nitrosamine Drug Substance-Related Impurities (NDSRIs) have emerged as a significant cause for concern within the pharmaceutical industry due to their potential to pose serious health risks to […]

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2024 Science of Stability Conference

Josh.Cosby

We were thrilled to co-host the 2024 Science of Stability Conference, alongside FreeThink Technologies, Inc. Taking place in Barcelona, Spain, the 8th SOS Conference showcased the latest stability science discoveries and innovations, covering key topics on accelerated aging, degradation chemistry, and stability. Featured presentations End points for forced degradation studies | Steve Baertschi, Ph.D., Baertschi

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2024 Pharmaceutical Industry and Regulators Symposium

Josh.Cosby

We were delighted to return to Brasilia this year to host the Pharmaceutical Industry and Regulators Symposium! Supported by Sindusfarma and the Federal Council of Pharmacy, this two-day event featured insightful presentations delivered by speakers from both industry and regulators. The Symposium brought together like-minded industry experts and regulators, offering attendees a unique opportunity to

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Read-across masterclass: How to facilitate your acceptable intake limit setting for nitrosamines

emma.scrafton

Read-across is a popular data gap filling technique which has recently gained recognition in regulatory guidance as a valuable tool for identifying suitable surrogates in establishing Acceptable Intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). We held an informative webinar where we unveiled Acrostic, our novel read-across solution designed to facilitate decision-making when determining

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Identifying the formation of nitrosamines via degradation pathways using an in-silico approach

lara.james

Ensuring the safety of active pharmaceutical ingredients (APIs) is of great importance. A critical aspect of this process involves the identification and mitigation of potentially mutagenic impurities, like nitrosamines. Our in silico tool Zeneth has been used within exploratory formulation departments to understand and account for potential degradation problems within the API at an early stage, resulting

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How to predict for the formation of NDSRIs (in Japanese)

emma.scrafton

We were delighted to host a webinar in Japanese, titled ‘How to predict for the formation of NDSRIs’. Nitrosamine Drug Substance-Related Impurities (NDSRIs) have become a major concern in the pharmaceutical industry due to their potential to pose serious health risks to patients. Understanding how to predict and manage the formation of NDSRIs is vital

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BTS Annual Congress

emma.scrafton

We were delighted to attend British Toxicology Society Annual Congress 2024 at Spaces at The Spine, Liverpool. The British Toxicology Society (BTS) promotes the importance and advancement of toxicology in scientific communities. During the conference, Lhasa Principal Scientist, Robert Foster, presented a poster titled “Computational modelling of genotoxicity assays: challenges & opportunities”. Robert also gave

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Genetic Toxicology Association Annual Meeting

emma.scrafton

The Genetic Toxicology Association (GTA) held its annual scientific meeting April 10-12th, in Delaware, Newark. Principal Scientist, Susanne Stalford presented a poster in collaboration with Toxys, the poster is titled ‘Association of the ToxTracker® Assay to Genotoxicity Adverse Outcome Pathways’. ToxTracker® is a next generation stem-cell based assay that utilises a combination of six unique fluorescent

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8th Impurities: Genotoxic, Nitrosamine & Beyond Summit

Josh.Cosby

We were delighted to attend the 8th Impurities: Genotoxic, Nitrosamine & Beyond Summit. Senior Application Scientist, Gabriela Silveira presented ‘Accelerating nitrosamine risk assessment: Meeting emerging regulatory guidelines’. In this talk, she discussed: – Use of in-silico tools on nitrosamine risk assessments – How data sharing and collaboration aid in nitrosamines assessments – Setting AIs using

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9th German Pharm-Tox Summit

lara.james

We were delighted to attend the 9th German Pharm-Tox Summit, on March 13–15, 2024, in Munich, Germany. The GPTS is organized by the German Society for Experimental and Clinical Pharmacology and Toxicology (DGPT) together with the Austrian Society of Toxicology (ASTOX), Austrian Pharmacological Society (APHAR) and the Association for Applied Human Pharmacology (AGAH). The program,

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Past

How to establish acceptable intake limits for NDSRIs (in Japanese)

2024 Science of Stability Conference

2024 Pharmaceutical Industry and Regulators Symposium

Read-across masterclass: How to facilitate your acceptable intake limit setting for nitrosamines

Identifying the formation of nitrosamines via degradation pathways using an in-silico approach

How to predict for the formation of NDSRIs (in Japanese)

BTS Annual Congress

Genetic Toxicology Association Annual Meeting

8th Impurities: Genotoxic, Nitrosamine & Beyond Summit

9th German Pharm-Tox Summit

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