SOURCES SOUGHT
A -- NIMH Toxicological Evaluation of Novel Ligands Program
- Notice Date
- 10/12/2007
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, MD, 20892-9661, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-SS-NIMH-70010
- Response Due
- 11/5/2007
- Archive Date
- 11/20/2007
- Point of Contact
- Mark Lohrmann, Contracting Officer, Phone 301-443-8886, Fax null, - Bruce Anderson, Contracting Officer, Phone 301-443-2234, Fax 301-443-0501
- E-Mail Address
-
lohrmannm@nida.nih.gov, ba9i@nih.gov
- Description
- The National Institute of Mental Health (NIMH) is seeking information on all sources capable of providing toxicology and safety assessment services to continue the NIMH Toxicological Evaluation of Novel Ligands Program. The program provides assessment of promising, target-selective ligands for PET, SPECT, and MRI imaging in humans, as well as limited assessment of novel psychoactive agents for clinical research and as potential therapeutics. Toxicology and safety data generated by the program are used to support Investigational New Drug (IND) applications to the Food and Drug Administration, or for Radioactive Drug Research Committee (RDRC) evaluation of a compound for human studies. Services to be provided under this program fall into four general areas: 1) analytical chemistry; 2) pharmacokinetics; 3) preliminary safety assessment; and 4) IND-directed toxicity assessments, including safety pharmacology. Capable sources will be required to (1) develop and validate analytical methods for quantitating drug concentrations in dosing solutions, biological fluids, and tissues and determine plasma drug levels in animals administered the agent under study and calculate pharmacokinetic parameters derived from these data; (2) Determine the bioavailability of a drug after different routes of administration; (3) conduct in vitro evaluation of hepatoxicity in human and animal liver cells; and (4) plan and conduct preclinical acute and chronic toxicity evaluations on lead compounds, including clinical observations, body weights, clinical pathology, and histopathology and plasma drug levels in rodents and non-rodent species, including safety pharmacology assessments.
- Record
- SN01433199-W 20071014/071012223502 (fbodaily.com)
- Source
-
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