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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

Note: this project is derived from the combination of 2 former projects in the Nonclinical WG: Endpoint Predictivity and Data Interconnectivity

NICE Members

  • Alan P. Brown (co-lead; Novartis)
  • Paul Brown (co-lead; US FDA)
  • Jyotsna Kasturi (Janssen R & D, Johnson & Johnson)

Conference Calls and Minutes

11 December 2013 Meeting Minutes
16 October 2013 Meeting Minutes
30 September 2013 Meeting 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