Newly Added Services to Support Latest Regulatory Guidance and Growing Demand for Alternative Testing Methods
Instem, a leading provider of IT solutions and services to the global life sciences market, announced that it has further enhanced its Predict In Silico Toxicology service portfolio by adding four new services.
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Predict™ is a leading edge, technology-enabled service that delivers a combination of powerful computation models with expert scientific review, to help clients predict chemical safety more quickly, efficiently, and comprehensively. Since its successful launch in December 2020, Instem has seen strong interest in the Predict™ service from clients across the globe.
These latest service offerings have been developed to address new regulatory guidance and will deliver further efficiencies and increased regulatory compliance for clients.
New service highlights:
- Establishing Acceptable Limits for N-nitrosamines – to support recent guidance from US FDA, EMA, and other regulatory authorities regarding the assessment and control of N-nitrosamine impurities and degradants.
- Assessment of Abuse Liability – provides an in silico assessment of abuse liability for CNS-active substances to support their assessment in early discovery, the development of a testing strategy for abuse liability, and to answer regulatory questions.
- Assessing Bioactivation – supports FDA guidance regarding the assessment of structural alerts for metabolites associated with mechanism-based inhibition (MBI). The service will generate and report the results of an in silico profile for MBI potential, including an expert review, and can also support the assessments of potential liver toxicity attributable to bioactivation.
- SD File Generation – The US FDA recommends that pharmaceutical companies submit an electronic format (SD File) for chemicals included in their regulatory submissions (including impurities). This Predict™ service offering will process the molecules, validate, and create an SD file.
Dr. Glenn Myatt, Instem’s Vice President of Informatics said, “We have been delighted to see such high demand for our Predict services from existing and prospective clients alike and are pleased to add these new offerings to our portfolio.” Dr. Myatt continued “As the demand for reliable alternatives to traditional testing methods continues to grow, organizations of all sizes are recognizing the benefits that our Predict™ service can deliver. This includes small and medium sized organizations that may not have the necessary team to perform an expert review, through to larger organizations with in-house expertise and technology, who are using Predict™ to complement their in-house capabilities or to assist during times of peak demand.”
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Predict™ leverages Instem’s expertise in delivering technology-enabled services, powered by advanced informatics and prediction technology, and comprehensive database solutions, that help organizations around the world unlock valuable knowledge contained in both public and proprietary sources of research data. Instem’s toxicity databases access well over 500,000 toxicology studies for more than 200,000 chemicals, enabling fast, accurate, defendable and regulatory-accepted predictions.
Predict™ harnesses these world-leading computational models and databases and combines them with expert scientific review by a team of professionals with deep knowledge of computation modelling, toxicology, and chemistry. This winning combination delivers comprehensive, unbiased, high quality, regulatory-accepted assessments of chemical safety.
The Predict™ service supports a variety of applications including the ICH M7 pharmaceutical impurities guideline, SD file generation to include in the Electronic Common Technical Document, assessment of extractables and leachables, and classification and labelling.
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