"How-To" Workshop

This workshop will address key questions related to in silico assessments recommended in ICH M7, such as:

• What defines an expert rule-based or statistical-based methodology?
• How should I choose which ones to use?
• How should I combine the results from the two methodologies to generate an overall prediction?
• When is expert review necessary?
• How should this be undertaken?
• What information should be provided to support any decision?
• What information from such an in silico analysis should be included in a regulatory submission?

Abstract

The ICH M7 guideline describes how to assess and control mutagenic impurities in pharmaceuticals to limit potential carcinogenic risk including the use of in silico predictions for regulatory submissions. Such in silico submissions require the use of two complementary methodologies (one expert rule-based, one statistical-based) and 'if warranted' the application of expert knowledge to review and provide sufficient evidence to support a conclusion - which may include refuting a prediction.

While the guidelines describe what to do, they do not specify the how, leading to a number of questions including: What defines an expert rule-based or statistical-based methodology? How should I choose which ones to use? How should I combine the results from the two methodologies to generate an overall prediction? When is expert review necessary? How should this be undertaken? What information should be provided to support any decision? What information from such an in silico analysis should be included in a regulatory submission?

This workshop aims to address these questions and will include practical hands-on training to ensure that the attendees feel comfortable and confident in applying these guidelines.

Resources

The following workshop resources are available for download.

Installation Files (password protected)

An evaluation copy of the Leadscope Model Applier can be downloaded from the appropriate link below for your PC's platform. This Model Applier installation is for the latest version (version 2.1) and includes access to all of the Leadscope Model and Alert Suites, both the SAR Genetox and SAR Carcinogenicity database modules and is licensed through June 16th, 2016.