The objective of this contract is to acquire pharmacologic and toxicologic data on new drug candidates for the treatment of cancer and other diseases, including orphan diseases. Cancer imaging agents with the potential for diagnosing and monitoring tumor progression are evaluated using this contract as well. These data are routinely submitted to the FDA as part of an investigational new drug (IND) application for a Phase I clinical trial, and as such will conform with all FDA Guidances. The work scope for this contract includes:a) Validation of analytical procedures for dose concentration analyses and for assaying drug candidate concentrations in biological fluids.b) Conduct pharmacokinetic studies in rodent and non-rodent species to determine plasma elimination kinetics. Determine bioavailability of non-parenteral routes and plasma clearance rates in order to establish the dose required to produce effective concentrations in plasma and apply the information to design drug candidate-specific toxicology studies.c) Conduct preliminary toxicology studies to establish relative toxicity of the drug candidate in rodent and non-rodent species and potential dose limiting toxicities.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM42200-13-0-1
Application #
7669673
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
2008
Total Cost
$1,230,594
Indirect Cost
Name
Battelle Centers/Pub Health Research & Evaluatn
Department
Type
DUNS #
007901598
City
Columbus
State
OH
Country
United States
Zip Code
43201