Is True In Vitro-Based Safety Assessment Possible?


By Yvonne Burkart posted 03-16-2016 08:54


Large amounts of in vitro data are being generated from high-throughput screening programs, and linking them to human exposure is paramount for their use in safety assessment.

As we move further away from animal models, more emphasis is placed on the reliability of these in vitro models. Such a global paradigm shift in the world of toxicity testing is exciting since years ago the idea of using in vitro data to make a safety assessment may have seemed like a pipe dream. Huge advancements in this field have been made and global regulatory bodies are considering these data in the decision-making process. The talks presented in the "Moving Beyond Prioritization Towards True In Vitro-Based Safety Assessment" workshop provided interesting insight into the current state of the science, applicability to real-life cases, and future directions for international consortiums and validation bodies.

As a user of several predictive in vitro assays and computational toxicology platforms, hearing updates from experts in the field was fantastic! Seeing the power of combining these data sets to estimate metabolic clearance and learning how they could model repeat exposure was one of my biggest take-aways. This area has often been a gap or area of weakness in my experience so the new information provided a great deal of confidence for my own work and provided a new way of looking at the currently available data. Noteworthy was the application of in vitro predictions towards human safety assessment for consumer goods. It's always reassuring when we see real-life examples of how this work can be used since this is the goal, right?

Personally, I would like to see more work in the area of in vitro to in vivo predictions of oral exposure. Although an OECD-approved protocol exists, perhaps the predictive power can still be improved if we incorporate more of the newly generated data sets from various screening programs.

Lastly, I felt particularly reassured that international validation committees, such as the European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM), are still actively working on reducing uncertainty with in vitro data. I'm optimistic that within the next few years, in vitro data can be used in regulatory decision making for approving compounds for use in commerce and consumer products.

BP2_5864-edit-Blog.jpgAttendees at the "Moving Beyond Prioritization Towards True In Vitro-Based Safety Assessment" Workshop Session