ICH M7 Features and Benefits
Lhasa Limited can help you to organise the relevant information for an ICH M7 submission. Using the ICH M7 functionality within the Nexus Suite, Derek and Sarah Nexus are brought together to provide the expert rule-based and statistical-based in silico predictions required under ICH M7. By additionally providing the Nexus Suite with information about the API, an ICH M7 calculation can be made which can take into account in-house or Vitic Nexus data.
- An ICH M7 classification is produced in the Nexus suite based on a calculation derived from the predictions provided by Derek and Sarah and any relevant experimental information (user added or provided by Vitic). Once a user has uploaded the impurities from a given synthetic scheme and defined the Active Pharmaceutical Ingredient, the ICH M7 functionality within the Nexus suite can be utilised and the calculation is provided.
- A table is produced which users are able to edit, comment on and save. Users can add their own mutagenicity and carcinogenicity data to the table to assist with their own expert review. This data is then utilised in the calculation of the ICH M7 classification.
- Supporting data is provided within the interface to aid an expert’s call. This includes mutagenicity and carcinogenicity data that is used within the Nexus suite, the former coming from the Lhasa Ames test reference set and the latter based on CPDB. If you have your own data stored in Vitic, the Nexus suite can automatically import it, organise it and use it to make the calculation.
- The ICH M7 functionality in the Nexus suite can process all of the relevant impurities from a synthetic scheme at once. The results, including any of the user’s own expert annotations, can be saved and stored.
- The Nexus platform is easy to use, and a calculation of an ICH M7 classification can be obtained rapidly by clicking on the ICH M7 prediction button. This provides a starting point for the expert review of impurities and can supplement ICH M7 submissions.
- Reports can be created in a range of formats and are customisable. These reports can be submitted to regulatory agencies as part of your ICH M7 submission.
ICH M7 Guideline
- The ICH M7 Guideline says that a “Hazard Assessment involves an initial analysis of actual and potential impurities by conducting database and literature searches for carcinogenicity and bacterial mutagenicity data in order to classify them as Class 1, 2, or 5 according to Table 1. If data for such a classification are not available, an assessment of Structure-Activity Relationships (SAR) that focuses on bacterial mutagenicity predictions should be performed”1.
- The ICH M7 classes are defined in the following table:
1ICH Harmonised Tripartite Guideline; Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; M7; Current Step 4 version; dated 23 June 2014.