NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS

The guidance provides recommendations for nonclinical evaluations to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options .Modification of “ standard ” nonclinical testing protocols generally is warranted to address novel characteristics associated with the pharmaceutical or with the manner in which it is to be used in humans .The HNSTD is defined as the highest dose level that does not produce evidence of lethality , life-threatening toxicities or irreversible findings .