PRECLINICAL PHARMACOLOGICAL STUDIES OF ANTITUMOR AND ANTI-HIV AGENTS

NIH GUIDE, Volume 23, Number 3, January 21, 1994



RFP AVAILABLE:  NCI-CM-57199-12



P.T. 34



Keywords:

  Pharmacology 

  Chemotherapeutic Agents 



National Cancer Institute



The Developmental Therapeutics Program (DTP), Division of Cancer

Treatment, 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 non-disease bearing animals on agents having

demonstrated antitumor or anti-HIV activity and considered by DCT 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 animal 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 administration to 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, 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 and is required by time of award.  It is anticipated that

four to five awards will be made as a result of the Request for

Proposal (RFP), each for a three to five year, incrementally-funded

level-of-effort contract.  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) since structural formulas and other information

on discreet agents may be included in a Task Order Request,

contractors must be willing to sign a confidentiality of information

statement; (3) the Contractor must possess a valid NRC license

permitting the purchase, storage, and use of typical quantities of

radioisotopes (e.g., 3H, 14C, 35S) likely to be used in the proposed

pharmacological research.



INQUIRIES



RFP No. NCI-CM-57199-12 will be issued on or about January 18, 1994

and proposals will be due approximately March 4, 1994.  Copies of the

RFP may be obtained by sending a written request to:



Ms. Joyce A. Crooke

Research Contracts Branch, TCS

National Cancer Institute

Executive Plaza South, Room 603

Bethesda, MD  20892

Telephone:  (301) 496-8620



No collect calls will be accepted.



.

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