The development of medications for the treatment of drug addiction is a major mission of the National Institute on Drug Abuse (NIDA). The Institute has been providing potential treatment drugs to investigators for use in preclinical toxicology evaluation, pharmacological studies and clinical trials. These drugs are acquired by the Government from private industry, Government contractors/grantees or independent investigators. In order to assure the identity, strength, quality and purity of these materials, the Government has been performing quality control tests before distributing them to the research community. The purpose of this contract is to carry out the work for the development of analytical methods, quality control tests, dosage form preparation, and performing stability studies for the compounds and dosage forms to be used in the medications development program. The Contractor shall carry out the tests in compliance with the Food and Drug Administration's (FDA's) current Good Manufacturing Practice regulations (cGMP) and Good Laboratory Practices (GLP). The data prepared should be adequate to support IND or NDA applications submitted by NIDA or NIDA supported investigators to the FDA.
