DEVELOPMENT OF DOSAGE FORMS AND DELIVERY SYSTEMS FOR ANTITUMOR AGENTS

Release Date:  December 12, 2001

NOTICE:  NOT-CA-02-008

National Cancer Institute

The Pharmaceutical Resources Branch of the Developmental Therapeutics Program, 
Division of Cancer Treatment and Diagnosis, National Cancer Institute 
(PRB/DTP/DCTD/NCI) is seeking contractors to develop acceptable dosage forms for 
compounds to be subsequently evaluated in cancer patients.  NCI will select and 
provide the compounds to be studied.  In addition to solubility studies, the 
projects may require analytical work, particularly the development of a 
stability-indicating assay to monitor the integrity of the parent compound 
during the formulation studies.  These investigations will be directed toward a 
pharmaceutical dosage form that will meet certain solubility and stability 
targets determined by the Government.  Data will be submitted to the Project 
Officer primarily in the form of progress reports but additional reports may be 
required.  The Contractor will be required to maintain laboratory notebooks 
containing raw data at the contract site.  The data will remain at the contract 
site but copies may be requested at the discretion of the Government.  The 
Contractors may be assigned compounds covered by a discreet agreement.  
Therefore, the contract will contain the current confidentiality clause in 
accordance with HHSAR 352-224-70.  The Principal Investigator on this project 
should possess a Ph.D. in Pharmaceutics or Medicinal Chemistry and should also 
have at least three years experience in the development of injectable 
formulations.  It is anticipated that three (3) cost-reimbursement term (level 
of effort) type contracts will be awarded for five (5) years.  The proposed 
contract project represents a re-competition of the following contracts:  
NO1-CM-77109  (University of Arizona), NO1-CM-77017 (University of Kansas), and 
NO1-CM-77108 (University of Utah).  All responsible offerors will be considered.  
The solicitation is scheduled for electronic release on December 6, 2001.  The 
RFP may be accessed through the Research Contracts Branch Home Page by using the 
following Internet address:  http://rcb.nci.nih.gov/.  It's the offeror's 
responsibility to monitor the above Internet site for the release of this 
solicitation and amendments, if any.

INQUIRIES

For further information contact:

Diane H. Stalder
Contract Specialist
Treatment, Biology and Sciences Section, RCB
National Cancer Institute
Executive Plaza South
6120 EXECUTIVE BLVD MSC 7220
Bethesda, MD  20892-7220
e-mail:  ds88b@nih.gov
voice:  (301) 435-3822
fax:  (301) 402-6699

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