Analytical Services Center for Medications Development Program
Location(s): United States
The objective of Task A is to develop and validate analytical methods to quantify new medications, metabolites, illicit drugs and endogenous biomarkers in plasma, urine and other biological matrices. The validated assays will be used for preclinical and clinical pharmacokinetic (PK) studies in order to support NIDA's medications development programs. The objective of Task B is to quantify a variety of compounds including new medications, their metabolites, illicit drugs and endogenous substances or biomarkers in plasma/serum, urine and other biological matrices, such as saliva or hair. The compounds to be quantified include, but are not limited to, the following drugs and their metabolites: cocaine, methamphetamine, naltrexone, and other potential medications under development, such as GSK 598809. Task C: One important aspect of medication development for treatment of abused drug addiction involves identifying the drug user by screening urine samples and the assessment of the medication in reducing the use of the target abused drug by participating subjects. This clinical outcome measure requires assay of urine samples for the abused drugs and their metabolites. This task can be divided into two parts: a) urine abused drug screening; and b) urine abused drug confirmatory/quantitative analysis. Task D: On-site drug testing devices can quickly identify the drug user and the common abused drugs. To support the clinical trial for abused drug treatment program, the Contractor will purchase and distribute 4-9 multi-panel urine on-site drug testing devices to each clinical site. Task E: Clinical trials for drug addiction treatment require collection of biological samples for analysis. To provide such services, the Contractor will purchase and supply all necessary sample collection and shipment containers, sample labels and shipment cartons, etc. to each clinical site. Task F: The Contractor shall prepare and maintain all assay results in electronic files for submission to NIDA with corresponding reports and for submission to the data management centers designated by NIDA. The objective of Task G is to archive and maintain all records, which includes laboratory notebooks, hard copies of raw data, and databases of assay results on disk in secure storage for a period up to 5 years in case a GLP audit is required by FDA in connection with an IND or NDA submission.