Primarily designed to track internal and external Ames and carcinogenicity data, and to ensure ICH M7* compliance, Setaria is also a platform for storing consensus Permitted Daily Exposure (PDE) and Acceptable Intake (AI) limits. Setaria performs Derek Nexus and Sarah Nexus predictions automatically when new compounds are uploaded, making the ICH M7 submission process semi-automated and therefore quicker and easier to complete.
Following a project phase with key Lhasa Limited members, Setaria is now being added to Lhasa Limited’s growing product portfolio. A major development since the final project phase release is the ability to generate Sarah predictions for compounds, if licensed. Other features and benefits of Setaria can be seen here.
By utilising Setaria’s unique functionalities, organisations can effectively meet the requirements under the ICH M7 guideline.
- Streamline the ICH M7 workflow by storing and tracking actual and potential impurities that are identified for further assessment. Furthermore, Setaria’s functionality extends to the storage of historical in silico predictions to aid in the meeting of regulatory compliance under ICH M7.
- Achieve efficiency in the drug development process, through storing searchable compound knowledge. When multiple individuals within an organisation are completing ICH M7 assessments simultaneously, common impurities may be assessed multiple times. Setaria can save time through the prevention of duplicated evaluations.
- Benefit from a cohesive integration of (Q)SAR prediction software and databases, including Lhasa Limited’s Derek Nexus, Sarah Nexus and Vitic. This functionality allows a user to pull toxicological data and predictions through to the Setaria database. This information can be stored, drawn upon, and tracked according to an organisation’s specifications, subsequently resulting in decreased duplication of effort, reducing the need for any unnecessary and costly Ames testing.
If you would like to know more about Setaria and how it can streamline your ICH M7 workflow, then get in touch.
* If you’re interested in ICH M7, you may be interested in our upcoming webinar taking place on 19th June.