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18 Cards in this Set
- Front
- Back
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Which organization is the primary agency for assuring the health and safety of Americans
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HHS (health and human services)
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Which organization is in charge of public health including health research, prevention of child abuse, health emergency preparedness and Medicare and Medicaid services?
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HHS (health and human services)
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which organization is the parent organizationfor many other agencies
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HHS (health and human services)
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Which organization is responsible for clinical drug trial oersight?
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FDA
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Which organization approves new drugs coming to market (including names of new drugs)
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FDA
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Which organization is responsible for black box warnings?
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FDA
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Which organization ios responsible for post-marketing surveillance and prevention of counterfeit drugs?
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FDA
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Which organization is responsible for tracking medication error data?
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FDA
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Does the FDA oversee vitamins and herbals?
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NO
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Which phase of clincal drug trial?
in vitro and animal trials to determine whether there is cause to proceed further |
Pre-clinical trials
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Which phase of clincal drug trial?
The first of human trials |
Phase 0
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Which phase of clincal drug trial?
micro-dosing trials |
Phase 0
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Which phase of clincal drug trial?
sample size is small groups of subjects (typically 10-15 people) |
Phase 0
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Which phase of clincal drug trial?
goal is to determine whether drugs behave in humans the way the preclinical studies suggests |
Phase 0
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Which phase of clincal drug trial?
Looks at the pharmacokinetic and pharmacodynamic issues, but not the safety or efficacy |
Phase 0
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Which phase of clincal drug trial?
First stage of SIGNIFICANT human testing (small groups of typically 20-80 healthy volunteers or ocassionally end-stage patients) |
Phase I
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Which phase of clincal drug trial?
First to assess safety, tolerability, pharmacokinetics, and pharmacodynamics |
Phase I
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Which phase of clincal drug trial?
Helpful in finding the correct dose range |
Phase I
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