Transcript FDA
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