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12 Cards in this Set
- Front
- Back
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The first American law to regulate drugs. This law was very weak & said nothing about drug safety or effectiveness. The only criteria was that the drug needed to be free of adultrents.
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Pure Food & Drug Act 1906
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This law was much stronger & was the first legislation to regulate drug safely. Motivation involved more than 100 people who died following use of new medication.
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Food Drug & Cosmetic Act 1938
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Passed in 1962. This law was created in response to the thalidomide tragedy that occurred in Europe during the early 60's.
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Harris Kefauver Amendments
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In 1970, Congress passed this act that sets rules for the manufacture & distribution of drugs considered to have potential for abuse.
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Controlled Substance Act
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Testing where drugs are evaluated for toxcitites, pharmo-kinetic properties & potentially useful bio effects. Takes 1-5yrs.
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Pre-clinical Testing
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This phase of testing has two goals. Evaluation of drug metabolism & determination of effects in humans.
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Phase 1
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Phases in drug trials where drugs are tested in patients. Objective is to determine theraputic effects & safety.
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Phases 2&3
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In this phase, the new drug is released for general use, permitting observation of its effects in a large population.
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Phase 4
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The drug name that constitues a description of the drug using the "Nomenclature of Chemistry". Eg. N-acetyl-para-aminophenol.
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Chemical Name
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The drug name that's assigned by the United States Adopeted Name Council. Also known as the nonproprietary name. This name is preferable to general use.
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Generic Name
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Also known as "Proprietary" or "Brand Name" (eg. Tylenol)
These are the drug names created by drug companies under which they are marketed. |
Trade Name
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In almost all cases, this drug name is longer than the trade name & can be more difficult to pronounce.
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Generic Name
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