FDA Health Psychology. FDA = Food & Drug Administration Part of Dept of Health & __________...
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Transcript of FDA Health Psychology. FDA = Food & Drug Administration Part of Dept of Health & __________...
FDA
Health Psychology
• FDA = Food & Drug Administration
• Part of Dept of Health & __________ Services
Products FDA Regulates
• Food & ___________ Supplements
• Drugs• Medical Devices• Biologics
• Animal Feed & Drugs• Cosmetics• ___________ -
Emitting Products
Stage 1: Preclinical Research
• Drug Discovered
• ___________ Research– Harmful effects– How works
• FDA: Investigational New Drug Application
Stage 2: Clinical Research
• ___________ clinical trials
• Overseen by: – pharmaceutical co– physicians– regulatory authorities– safety & ethics
committee
Phase I
• ___________ volunteers, not taking other meds
• Small groups
• Determines: How body processes, responds to, is affected by drug
• Test low & high ___________
Phase II
• Pts w/ disease or disorder only, no other meds
• Small controlled trials
• Determines: drug's _______________, side effects, general effectiveness
Phase III
• Pts w/other diseases/disorders, other meds
• Large controlled trials
• ___________
Phase IV
• After initial FDA approval
• Specific populations
• More safety investigations
Stage 3: FDA Review & Approval
• New Drug Application– pharm co reports all results to FDA
• Approval if safe & ___________
Stage 4: Marketing
• Drug available to drs & pts
• For ___________ only
• Maybe research on other uses
Controlled Trials
• Placebo: pt thinks getting something
• ___________ _______: all get some drug
• Active-tx: other known effective drug
• No tx
• Historical: compare past mortality rates
Placebo Types
• Sugar pills
• Waiting
• History-taking
• Injections• _________________
• Active placebos
Placebo effects
• ~ ___% of clinical effect
• Often bigger than drug’s effect
• Placebo addiction & withdrawal
Individual characteristics
• Older
• Women
• ___________
• Hi neuroticism
Psych Factors
• Expectancy–Faith, hope,
suggestibility–Pt & ________
–Pos & neg
• Credibility–Of dr & tx– Ointment<pill<injection
Mechanisms
• Spontaneous remission
• Classical conditioning
• Cognitive theory
• _______________
• Physiological explanations