The U.S. Congress recently passed the FDA Modernization Act 2.01 which permits the use of alternatives to animal studies as part of the FDA’s regulatory approval process. The new legislation explicitly identifies in silico models as one of these alternatives.
This legislation is an important step forward in the use of alternative methods and will encourage the use of scientifically valid alternative methods to support the assessment of a drugs’ efficacy and safety. Since many of these alternative methods, especially in silico models, generate results rapidly, they can be deployed strategically throughout the drug discovery and development process to accelerate product development.
Please reach out to me if you would like to discuss in silico toxicology models in more detail (email@example.com).