Regulatory agencies like the EPA and FDA are exploring innovative methods to enhance toxicology testing and clinical trials. These new approaches, known as new approach methods (NAMs) and modeling technologies, aim to streamline processes, reduce costs, and uphold ethical standards.
In silico modeling, which utilizes computer models to simulate biological processes, is a promising technique that predicts potential side effects and risks before proceeding to clinical trials. Additionally, 3-D cell cultures and organoids offer a more accurate representation of human biology, enabling researchers to make more informed decisions. These novel approaches are not only cost-effective but also hold the potential for personalized medicine.
Battelle, a renowned research organization, has been utilizing similar models for several years and recently employed computational fluid dynamics modeling to evaluate the toxicology of Chlorothalonil, a fungicide. The EPA accepted the findings of this study, marking a significant milestone as it was the first time a chemical compound was reauthorized using new approach methodologies. Furthermore, these modeling methods can be adapted for various medications, including inhalers and nasal-administered drugs. By embracing these advancements, regulatory agencies can revolutionize toxicology testing and clinical trials, paving the way for safer and more efficient drug development.