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FDA

FDA. Health Psychology. FDA = Food & Drug Administration Part of Dept of Health & __________ Services. Food & ___________ Supplements Drugs Medical Devices Biologics. Animal Feed & Drugs Cosmetics ___________ -Emitting Products. Products FDA Regulates. Stage 1: Preclinical Research.

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FDA

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  1. FDA Health Psychology

  2. FDA = Food & Drug Administration • Part of Dept of Health & __________Services

  3. Food & ___________ Supplements Drugs Medical Devices Biologics Animal Feed & Drugs Cosmetics ___________-Emitting Products Products FDA Regulates

  4. Stage 1: Preclinical Research • Drug Discovered • ___________ Research • Harmful effects • How works • FDA: Investigational New Drug Application

  5. ___________ clinical trials Overseen by: pharmaceutical co physicians regulatory authorities safety & ethics committee Stage 2: Clinical Research

  6. Phase I • ___________ volunteers, not taking other meds • Small groups • Determines: How body processes, responds to, is affected by drug • Test low & high ___________

  7. Phase II • Pts w/ disease or disorder only, no other meds • Small controlled trials • Determines: drug's _______________, side effects, general effectiveness

  8. Phase III • Pts w/other diseases/disorders, other meds • Large controlled trials • ___________

  9. Phase IV • After initial FDA approval • Specific populations • More safety investigations

  10. Stage 3: FDA Review & Approval • New Drug Application • pharm co reports all results to FDA • Approval if safe & ___________

  11. Stage 4: Marketing • Drug available to drs & pts • For ___________ only • Maybe research on other uses

  12. Controlled Trials • Placebo: pt thinks getting something • ___________ _______: all get some drug • Active-tx: other known effective drug • No tx • Historical: compare past mortality rates

  13. Sugar pills Waiting History-taking Injections _________________ Active placebos Placebo Types

  14. Placebo effects • ~ ___% of clinical effect • Often bigger than drug’s effect • Placebo addiction & withdrawal

  15. Individual characteristics • Older • Women • ___________ • Hi neuroticism

  16. Expectancy Faith, hope, suggestibility Pt & ________ Pos & neg Credibility Of dr & tx Ointment<pill<injection Psych Factors

  17. Mechanisms • Spontaneous remission • Classical conditioning • Cognitive theory • _______________ • Physiological explanations

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