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The Development of Medications for the Treatment of Opiate and Cocaine Addictions Issues for the Government and Private Sector (1995) / Chapter Skim
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Appendix B: Organization and Mission Statements of NIDA's Medications Development Division and Its Branches
Pages 207-210

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From page 207...
... develops and administers a national program of basic and clinical pharmaceutical research to develop innovative biological and pharmacological treatment approaches; (3) supports training in the fundamental sciences and clinical disciplines related to the pharmacotherapeutic treatment of drug abuse; (4)
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From page 208...
... new rapid screening projects which generate pharmacological activity and storage of such data in a computer database and coordination of screening programs with other sources of data of potential interest to the Division; (3) provides analytical chemistry development and services including development of assay methods for applications of drug characterization, bioavailability and kinetic studies in the Division, and centralized analysis of biological specimens (e.g., urine for cocaine use detection)
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From page 209...
... provides liaison, consultation, and collaboration with the Food and Drug Administration and the pharmaceutical industry on matters related to preclinical models of drug abuse and drug dependence. Regulatory Affairs Branch Mission Statement (1)
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From page 210...
... Liaisons with: - FDA NIH Office of Technology Transfer Chemistryl Biometrics Pharmaceutics Branch Rr~n~h Clinical Trial Capability (Pharmacokinetic studies and phases 1, 11, and 111) through: Veterans Affairs medical centers · Treatment research units University medical centers · NIDA Addiction Research Center · Product development · Protocol design · Bulk synthesis · Clinical data management Pharmacokinetic studies Statistical anaysis (~rough contracts)
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Key Terms

  • clinical trials
  • provides consultation
  • affairs branch
  • abuse disorders
  • comprehensive program

  • potential medications
  • regulatory affairs
  • substance abuse
  • drug applications
  • dosage forms

  • trials branch
  • preclinical pharmacological
  • drug application
  • maintains liaison
  • intramural projects

  • drug dependence
  • medical centers
  • recommends compounds
  • marketed drugs
  • preclinical models

  • pharmaceutical industry
  • regarding medications
  • branch mission
  • drug abuse
  • analysis issues

  • issues involved
  • pharmacological models
  • screening projects
  • drug metabolism
  • mission statement


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