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7 Cards in this Set
- Front
- Back
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The first American law to regulate drugs was
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the Federal Pure Food and Drug Act of 1906.
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first law to address drug safety
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Food, Drug and Cosmetic Act, passed in 1938
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Drugs in Schedule I
examples |
have no accepted medical use
deemed to have a high potential for abuse. ex: heroin, mescaline, and lysergic acid diethylamide (LSD). |
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The testing of new drugs has two principal steps:
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preclinical testing (animals)
and clinical testing (humans) |
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Phase I testing has three goals:
subjects: |
evaluating drug metabolism, pharmacokinetics, and biologic effects.
done in healthy volunteers |
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Phase 2 testing three goals:
subjects: |
determine therapeutic effects, dosage range, safety, and effectiveness.
tested in patients |
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Drugs have three types of names:
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(1) a chemical name, (2) a generic or nonproprietary name, and (3) a trade or proprietary name.
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