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NOT-DA-06-021: Pharmacokinetic & Pharmacodynamic Studies for Medication Development

Pharmacokinetic & Pharmacodynamic Studies for Medication Development


Notice Number:  NOT-DA-06-021

Key Dates
Release Date: April 5, 2006

Issued By
National Institute on Drug Abuse (NIDA)

The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having the capability to carry out clinical studies to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of new medications for drug abuse treatment.  As medications are often taken with other treatment drugs or drugs of abuse (such as cocaine, methamphetamine, etc), information on the extent and nature of the interaction between the medications and other treatment drugs/drugs of abuse will also be a focus of this contract.  Such studies require the intravenous administration of abused drugs, such as cocaine and methamphetamine, to human subjects.  Since a prerequisite for PK studies is the availability of specific assay methods for the quantitative determination of drugs and their metabolites in biological fluids (e.g. plasma, urine, feces, saliva, sweat, etc), this project also includes the development and validation of analytical methods, identification of metabolites, and quantification of drug/metabolites in biological samples collected from the clinical studies.  In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances.  The offerors must have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects and must have a board certified physician on the project

The data obtained will be submitted to the Food and Drug Administration (FDA) in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications).  All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations.  The pertinent FDA's guidelines/guidance shall be followed.  It is estimated that a three‑year incrementally funded completion‑type contract with options to extend up to two additional years & additional option quantities. RFP No.  N01DA-6-8867 will be available electronically on or about April 17, 2006.  You can access the RFP through the FedBizOpps http://www.fedbizopps.gov or through the NIDA website at the following address: http://www.nida.nih.gov/RFP/RFPList.html. The electronic RFP contains all information needed to submit a proposal. No printed version of the solicitation document or source list is available. NIDA will consider proposals submitted by any responsible offeror. Proposals will be due on or about June 1, 2006. This advertisement does not commit the Government to award a contract.

Point of Contact:

Amy Pasciak, Contract Specialist
National Institute on Drug Abuse, NIH
Contracts Management Branch, OPRM
6101 Executive Blvd., Room 260, MSC 8402
Bethesda, Maryland  20892-8402
E-mail: ap370t@nih.gov
Telephone: (301) 443-6677
Fax:  (301) 443-7595

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