The primary objective of this project is to develop and produce Pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer or the HIV virus. Certain agents selected by the NCI, DCTDC, Cancer and AIDS operating committees will be assigned for development and production as parenteral products (primarily sterile freeze dried products). Batch sizes will range from small development batches (less than 100) to intermediate size batches to be used in Phase I and II trials; however, escalation to large batch Size (10-30,000 or more) for Phase III/IV trials and Group C distribution is possible. It is estimated that the successful offerors must be prepared to supply more than five-hundred thousand parenteral dosage units each year. The capability to develop and manufacture other pharmaceutical dosage form (i.e. large volume parental, sterile emulsions, sterile micro-dispersions, etc) is desirable but not essential. Data obtained from the contract will: 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms and 3) be provided to physicians, pharmacists, and nurses and other medical personnel handling these products in a clinical setting.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM077020-002
Application #
6094661
Study Section
Project Start
1997-09-30
Project End
2002-09-29
Budget Start
1999-06-30
Budget End
2000-09-29
Support Year
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Ben Venue Laboratories, Inc.
Department
Type
DUNS #
City
Bedford
State
OH
Country
United States
Zip Code
44146