Preclinical toxicology of drugs developed for cancer patients

The Development Therapeutics Program (DTP) of the National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is soliciting preclinical toxicology of drugs developed for cancer patients. Investigations that profile and characterize the toxicological risk of these compounds to healthy organs are essential to the preclinical development phase for potential new drugs. Data generated from these studies are evaluated in light of potential human toxicity risk and additionally, form a major portion of the information required by the Food and Drug Administration for an Investigational New Drug Application (IND). Such laboratory investigations comprise the primary responsibility of this concept and of the Toxicology & Pharmacology Branch (TPB) within the DTP.

Toxicology studies conducted under these contracts are designed to meet this objective by providing: characterization of dose limiting toxicities (DLT); determination of schedule-dependent toxicity; determination of the reversibility of adverse effects; determination of a safe clinical starting dose via a margin of safety determination. Toxicology studies conducted under these contracts are designed to meet this objective by providing: characterization of dose limiting toxicities (DLT); determination of schedule-dependent toxicity; determination of the reversibility of adverse effects; determination of a safe clinical starting dose via a margin of safety determination.

(Please see attached documents for full synopsis)