Nonclinical Data Interconnectivity for Endpoint Predictivity (NICE)
Goals of the project
Explore means by which nonclinical and clinical data can be interconnected in ways that facilitate their use for identifying hazards and risks of pharmaceuticals.
Possible projects to explore:
- Using compound metadata for evaluating nonclinical data and making predictions for clinical safety based on known safety issues for a drug class
- Developing data analysis flow charts
- Identifying and discussing software/in silico predictivity tools
- Collaborating with other clinical working groups on predictivity
- Alan P. Brown (co-lead; Novartis)
- Paul Brown (co-lead; US FDA)
- Jyotsna Kasturi (Janssen R & D, Johnson & Johnson)
Conference Calls and Minutes
FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.
Last revision by APBrown,04/10/2014