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Pharmaceutical Technology's In the Lab eNewsletter
Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.
On Jan. 30, 2018, the National Toxicology Program (NTP), a federal interagency program under the National Institutes of Health (NIH) that focuses on identifying substances that may affect public health, published a roadmap that aims to provide more human-relevant toxicology data while reducing the use of animals.
The report, A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States, was developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM enables the development of toxicological testing methods that replace, reduce, or refine the use of animals. The committee includes representatives from United States federal agencies that use, generate, or disseminate toxicological and safety testing information.
According to NIH, the roadmap, which is the collaborative effort of 16 federal agencies, was developed to guide the application of new technologies, such as high-throughput screening, tissue chips, and computational models, to toxicity testing of chemicals and medical products.
The guideline includes the following goals:
According to NIH, objectives described in the roadmap identify activities that should be undertaken by regulatory agencies, test-method developers, regulated industries, funding agencies, and other stakeholders to achieve these goals. These activities, which focus on acute systemic toxicity, eye and skin irritation, and skin sensitization, are already underway, with ICCVAM workgroups developing detailed implementation plans to address roadmap goals tailored to specific toxicological endpoints of concern, as stated by NTP.
In September 2017, presentations at the Scientific Advisory Committee on Alternative Toxicological Methods meeting described implementation of the roadmap for skin sensitization and acute systemic toxicity testing. Reviews of US agency information requirements and decision contexts for these areas, as well as for skin and eye irritation, are being prepared for publication later in 2018. ICCVAM will sponsor a session on the roadmap at the Society of Toxicology meeting in March 2018 and in several other scientific meetings during spring 2018.
“This roadmap represents a coordinated effort by federal government agencies to proactively develop and adopt new approaches to toxicity testing, rather than having changes driven by external influences,” said Warren Casey, PhD, director of NTP Interagency Center for the Evaluation of Alternative Toxicological Methods, in an agency press release. “If actionable progress in this area is going to happen, the agencies need to take the lead, and that is exactly what they are doing with this roadmap.”