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16 Cards in this Set
- Front
- Back
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5 steps of the drug approval process |
Drug discovery & development Preclinical Clinical FDA reviews NDA Manufacturing |
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Preclinical phase |
Initial synthesis of substance Lab studies & animal testing Institutional Review Boards |
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Clinical phase |
Research & development-all trials approved by IRB Testing in healthy subjects Testing in healthy subjects w/ the disease Large scale testing including people suffering from the disease |
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FDA reviews NDA |
FDA expects review data
Company addresses FDA concerns Advisory hearing may be called |
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Manufacturing phase |
Drug appears on the market Post-market surveillance Follow up studies and inspections |
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The set of drug standards used in the US is |
United States Pharmacopenia of 1920 |
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Every aspect of a drug is discussed in |
U.S. Pharmacopeia National Formulatory |
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The best seal of approval you can see on a drug is |
USP |
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7 drug resources |
American Hospital Formulatory Service Drug Info U.S. Pharmacopeia-Drug Info Physicians Desk Reference Handbook of injectable drugs Nursing Drug Handbooks Package inserts Internet to include medline plus |
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The primary purpose of federal legislation of drugs is to |
Ensure safety |
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1938 Food Drug & Cosmetic Act |
Ensures safety by requiring all drugs to be tested, correctly labeled, and that the drug has enclosed literature explaining adverse effects. |
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Schedule 1 |
No accepted medical use. Heroin, LSD, marijuanna |
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Schedule 2 |
High potential for drug abuse. Accepted medical use. Can lead to strong physical and psychological dependancy. Morphine, methadone, oxycodone, amphetamines. |
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Schedule 3 |
Medically accepted drugs. Potential abuse is less than that of 1 & 2. May cause dependency Codeine preparations-tylenol. |
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Schedule 4 |
Medically accepted drugs. May cause dependence. Diazapam, phenobarbital. |
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Schedule 5 |
Medically accepted drugs, very limited potential for dependence. Opiod controlled substances for diarrhea & cough. Lomotil, Robitussin, A-C. |
