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 drug substances and dosage forms to be used in the medications development program. 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. The treatment drugs include both bulk drug substances (e.g., ibogaine, buprenorphine, and naltrindole) and dosage forms (e.g., buprenorphine alcoholic solution, l-alpha-acetylmethadol concentrate, and naltrexone sustained-release preparations). 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 Contractor is responsible for developing and validating analytical methods, carrying out assays, preparing dosage forms, and performing stability testing. In addition, the Contractor provides adequate facilities for the storage of drug substances and finished dosage forms. The Contractor is expected to make a limited number of shipments of drug substances and dosage forms to NIDA designated sites. The Contractor also maintains an up-to-date tracking system to track the status of all drug substances and drug products being studied under this contract. It is also necessary for the Contractor to track all drug products and drug substances in various stages of stability testing. The Contractor carries 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).
