For users who are new to ICH M7 expert review, identifying the correct information from the in silico output can be tricky. Often the way out of this situation is to use supporting information from one in silico tool to overturn the conclusion of the other. For example, some of the more difficult predictive scenarios arise when Derek and Sarah return conflicting results.

In chemical synthesis different routes using the same starting materials can lead to different products similarly, in expert review you can follow different arguments to get to different conclusions.Īlso, much like synthetic processes, some expert review arguments are far simpler and easier than others. To continue our Chemistry analogy, we can say that expert review is like a synthetic route you are combining the raw materials – Derek and Sarah outputs – to get to a final product – the overall conclusion for mutagenicity. Essentially, Derek and Sarah predictions give the raw materials for the expert to build their own conclusions and ultimately convert in silico outputs into business-critical decisions.

This information can then be picked out by the user to support their own, human conclusion. With this in mind, Derek and Sarah predictions were designed to show the user detailed information to support the results. Even the best in silico models will be limited by the data and methodology used to build them, so an in-depth understanding of results is extremely important for those tasked with expert review. I’ll also show some worked examples of results from the new system.Įxpert Review: here are your “raw materials”…ĭerek Nexus (an expert tool) and Sarah Nexus (a statistical tool) are Lhasa’s solution for ICH M7 hazard assessments. In this post we discuss how consideration of the user’s journey led to Lhasa tackling the ICH M7 use case with a brand-new automated workflow, now available to Derek and Sarah users in Nexus 2.3.

In his blog “Human review of in silico predictions of toxicity”, Principal Scientist, Alex Cayley, outlined the reasons why expert review is essential when using in silico tools to assess toxicity, particularly in the ICH M7 use case where expert review of two complementary in silico systems is required.

Into the nexus review download