National Cancer Institute, Acquisition Management Branch, TBS, 6120 Executive Blvd, EPS/Rm 603 Bethesda, MD 20892-7220

A -- PRECLINICAL PHARMACOLOGICAL STUDIES OF ANTITUMOR AND ANTI-HIV AGENTS SOL N01-CM-97019-58 DUE 041599 POC Michael Veesart (301) 435-3815 WEB: Natioanal Cancer Institute's Research Contracts and, http://amb.nci.nih.gov. E-MAIL: Michael Veesart, Contract Specialist, mv64b@nih.gov. The Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) of the National Institutes of Health (NIH) is soliciting organizations having the necessary experience, scientific and technical personnel and facilities to conduct a series of preclinical pharmacokinetic and other pharmacology studies in animals on agents having demonstrated antitumor or anti-HIV activity and considered by DCTD to merit further development. The studies to be performed will include: the development of methodology for the quantitative measurement of test agents and/or metabolites in body fluids and tissues; stability studies of test agents in biological fluids; plasma protein binding determinations; characterization of in vivo plasma concentration-time profiles and calculation of relevant pharmacokinetic parameters; determination of test agent levels in samples provided by other DTP contractors; determination of the most effective mode of agent administrationto achieve and maintain effective concentrations in body fluids and tissues; bioavailability studies following administration of an agent by various routes; tissue distribution and urinary excretion studies; structural determination of metabolites and/or degradation products of parent agents produced in animals and in model in vitro systems (e.g., animal and/or human liver slices, hepatocytes, S9 fractions, and microsomal preparations). Where appropriate, this information will be related to mechanisms of antitumor or antiviral action. The Government will supply all animals (mice, rats, dogs, non-human primates), test agents, and radiolabeled test agents. Contractors will be expected to provide all equipment, solvents, reagents and animal facilities needed to conduct this type of work. AAALAC accreditation is highly desirable. It is anticipated that five or six awards will be made as a result of the Request for Proposal (RFP), each for a five-year, incrementally-funded completion type contract. Offerors have the opportunity to propose studies at two levels: one compound per year or equivalent or two compounds per year or equivalent. Only one award will be made to an institution. The following Mandatory Qualification Criteria will apply: (1) the Contractor may not be a pharmaceutical or chemical firm since agents of a commercially confidential nature (discreet) may be evaluated; (2) the Contractor must possess a valid NRC license permitting the purchase, storage and use of typical quantities of radioisotopes (e.g., 3H, 14C, 35S) are likely to be used in the proposed pharmacological research. SIC for this acquisition is 8731. The solicitation is scheduled for electronic release on or about February 16, 1999. The RFP may be accessed through the Research Contracts and Acquisition Branch homepage by using the following internet address -- http://amb.nci.nih.gov/RFP.htm. It is the offeror's responsibility to monitor the above internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERERS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. No collect calls will be accepted. Posted 01/19/99 (W-SN288975). (0019)

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