DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS FOR CLINICALSTUDIES

 

NIH GUIDE, Volume 25, Number 34, October 11, 1996

 

RFP AVAILABLE:  NCI-CM-77020-10

 

P.T. 34



Keywords:

  Dosage Forms+ 

  Metabolic Diseases 

  AIDS 

 

National Cancer Institute

 

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 volumes parenteral, sterile emulsions,

micro-dispersions, etc.) is desirable but not essential.  Data

obtained from the contract will: 1) be used to support IND

applications submitted by the NCI 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.  It is anticipated that two cost reimbursement,

completion type contracts will be awarded for a base period of three

years with two one-year options for each contract.  The offeror must

be registered with the FDA as a  pharmaceutical manufacturing

facility for sterile products at the time of proposal submission.

 

INQUIRIES

 

Therese Dick

Research Contracts Branch

National Cancer Institute

6120 Executive Boulevard, Room 603 - MSC 7220

Bethesda, MD  20892-7220

Telephone:  (301) 496-8620

No collect calls accepted.

 

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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