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Setaria

Project-centric, knowledge-searchable database for the storage of toxicity data to manage impurity assessments under ICH M7.

  • Setaria ensures ICH M7 compliance by storing ICH M7 data and expert conclusions, all in one accessible database.
  • Setaria provides visibility and traceability between departments, reducing duplication of effort in testing.
  • Setaria stores historical in silico predictions to monitor how alerts change over time.

‘Setaria saves significant time when searching for genotoxicity findings and has delivered improved visibility of our data across the business’ Jim Harvey – Head of Computational Toxicology, GSK.

Why do you need Setaria?

General Approach

Setaria and ICH M7

Setaria within the ICH M7 Workflow

 

Features and Benefits

 

Why do you need Setaria?

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.

General Approach 

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.

Setaria promotes interrogation of in-house data, to improve (Q)SAR predictions through internal data sharing. With the ability to store and generate results from Vitic, Derek Nexus and Sarah Nexus, Setaria provides individual organisations with a unique database repository, supporting mutagenic impurity management within the drug candidate development process.

Setaria facilitates the undertaking of ICH M7 assessments as well as regulatory compliance through the storing and tracking of:

  • actual and potential impurities identified for further assessment,
  • summarised mutagenicity & carcinogenicity data,
  • (Q)SAR predictions,
  • conclusions from expert review,
  • additional supporting information including exposure limits.

Setaria and ICH M7

Setaria assists with ICH M7 assessments by enhancing data visibility, reducing duplication of effort and ensuring consistent application of existing expert conclusions across an organisation.

By centralising (Q)SAR prediction data and expert conclusions, Setaria acts as a single point of truth for individual chemical entities within an organisation, enabling risk management across discovery programs.

Setaria within the ICH M7 Workflow

Setaria stores all ICH M7 data and expert conclusions. By notifying the user of the existence of an impurity within the database, Setaria allows an individual user to access pre-existing data and expert conclusions from within the database and from across their organisation, reducing duplication of effort and effectively assisting in regulatory compliance.

In the absence of data and expert conclusions for an impurity, the user is able to generate data from integrated (Q)SAR systems, make an expert conclusion, and store all of the knowledge within Setaria for future users within the organisation to access.

References 

  1. Drewe, W, C. (2018) ‘Enhancing the ICH M7 Workflow through Setaria’, Lhasa Limited Website Library, December.

 

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