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Cards In This Set
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Pharmacology is the...
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Study of drugs and their interactions with living systems
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A drug is...
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Any chemical that can affect living processes. all the processes of chemistry apply to drugs
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Chemical name
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Describes the chemical composition and structure (eg. N-acetyl-para-aminophenol)
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Generic name
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Nonproprietary (no one owns the generic name), official name(eg. acetaminophen)
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Trade/Brand name
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Proprietary name, selected by the drug company. Usually easier to say and remember. Copyrighted.(eg. Tylenol)For the first seven years of a new drug, it is not available in generic form.
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Sources of drugs
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Plants, animals and humans, minerals, synthetic or chemical substances
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Food, Drug and Cosmetic Act (1938)
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Drugs must be tested for harmful effects and labels have to be accurate and complete
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Kefauver-Harris Act (1962)
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More controls over drug safety, testing and effectiveness
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Controlled Substances Act (1970)
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Categorized controlled substances based on abuse potential (Schedule 1 drugs - street drugs like cocaine and heroine) and established the DEA
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PDUFA (1992 and 1997)
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Prescription Drug User Fee Act
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Food and Drug Administration Modernization Act (1997)
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Fast track system for drugs for serious illness (eg. AIDS, HIV)
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FDA
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Regulatory body that enforces food, drug and cosmetic act, and also is the home of the adverse reaction reporting program.
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Public Health Service
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Regulatory body that is part of USDHHA, regulates biologic products (blood, hormones, insulins, etc.)
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Bringing a drug to market takes...
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15 years from concept to market
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How many drugs actually enter trial phase?How many are actually approved?
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Actually enter trial phase - 5/5000 Actually approved - 1/5000
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