PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS DEVELOPED FORCANCER, AIDS AND AIDS-RELATED ILLNESSES NIH GUIDE, Volume 25, Number 34, October 11, 1996 RFP AVAILABLE: NCI-CM-77028-30 P.T. 34 Keywords: Cancer/Carcinogenesis AIDS Toxicology Pharmacology National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Treatment, Diagnosis and Centers (DCTDC), Development Therapeutics Program (DTP) anticipates the award of five cost-reimbursement contracts, for a five year period beginning August 30, 1997. As a minimum requirement, the contractors must perform all toxicology studies in accordance with the FDA's current Good Laboratory Practice (GLP). Contractors must also indicate their willingness to sign a confidentiality of information statement. The proposed awarded contracts will be administered on a work assignment managed basis. Offerors are required to proposed levels of effort for both levels: Level A: 46,875 labor hours, and Level B: 93,750 labor hours over a five year period. DTP is seeking organizations to carry out pharmacology and toxicology studies, the data from which must be suitable for filing with the FDA as part of Investigational New Drug Applications Offerors should have the facilities and staff to carry out such studies and the management expertise to analyze and evaluate the data. Work assignments are estimated to involve two or three chemical agents annually per contract. The objectives of the assignments in relative order of importance are: (1) assessment or acute and subacute toxicity in rodents and dogs including determination of a maximum tolerated dose (MTD), of dose limiting toxicities (DLT), schedule-dependent toxicity, of the reversibility of adverse effects and of a safe clinical starting dose; (2) validation of analytical methodology to quantitate plasma drug levels in preclinical animal models and to measure plasma drug levels in rodents, dogs, and/or non-human primates treated with the agents under study, (3) determination of bioavailability of drug after parenteral and/or oral administration if efficacious drug levels can be attained in plasma in vivo and is the drug crosses the blood-brain barrier, (4) the use of pharmacokinetic information to permit extrapolation of toxic effects across species by relating plasma drug levels to the time of appearance and severity of toxicity, and to establish the safety of potentially efficacious doses. The Principal Investigator should have a doctoral degree in pharmacology/toxicology plus at least five years experience in directing, implementing and evaluating drug toxicity studies in experimental animals. The pathologist, pharmacokinetics and analytical chemist should likewise have credentials which illustrate their competence and accomplishment in service as critical team members in the conduct of such studies. This is a recompetition of a group of 5 contractors currently performing these activities. The Request for Proposal will be available on or about October 18, 1996. No collect calls accepted. Requests for the RFP may be directed to: Elsa B. Carlton Research Contracts Branch National Cancer Institute 6120 Executive Boulevard, Room 603 - MSC 7220 Bethesda, MD 20892-7220 Telephone: (301) 496-8620 .
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