Nonclinical Evaluation for Anticancer Pharmaceuticals

• Date: March 09, 2010
• Source: www.fda.gov

There have been no internationally accepted objectives or recommendations on the design and conduct of nonclinical studies to support the development of anticancer pharmaceuticals in patients with advanced disease and limited therapeutic options. Hence FDA recently produced a draft guidance whose aim is to establish an internationally accepted objectives /recommendations on how to design and conduct  nonclinical studies for development of anticancer pharmaceuticals in patients with advanced disease and limited therapeutic options.

The purpose of this guidance is to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. This guideline aims to facilitate and accelerate the development of anticancer pharmaceuticals and to protect patients from unnecessary adverse effects, while avoiding unnecessary use of animals and other resources.

This guideline provides information for pharmaceuticals that are only intended to treat cancer in patients with late stage or advanced disease regardless of the route of administration, including both small molecule and biotechnology-derived pharmaceuticals. This guideline describes the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals and references other guidance as appropriate.

 

Click here to download the file