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| applied science that concerns itself with the fate and actions of drugs in the body |
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| pharmacology includes which studies? |
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| pharmacodynamics, pharmacokinetics, pharmacogenomics, and toxicology |
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what the body does to a drug (ABCD)
includes Absorption, Distribution, Biotransformation, time Course of action |
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what the drug does to the body
includes its effects, mechanism of action, and location of action |
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| what role do genetic factors play in pharmacokinetic and pharmacodynamic actions |
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| working definition of DRUG |
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| any chemical substance used in the diagnosis and treatment of disease |
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| group of young men who volunteered to eat foods treated with measured amounts of chemical preservatives to measure safety |
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| 1906 Wiley Act/Federal Pure Food and Drug Act |
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-Bureau of chemistry
-prohibits misbranded or adulterated foods, drinks, or drugs and no false claims on labels
-also registration and listing of addicting substances |
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| T/F In 1911 the supreme court ruled that the 1906 act did not prevent false therapeutic claims on labels |
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| prohibited fraudulent therapeutic claims |
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elixir of sulfanilamide
-107 deaths associated with its use in 1937, many children
-important for the FDC act of 1938 |
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| 1938 Federal Food, Drug, and Cosmetic Act |
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Definition
-required safety testing
- labels to be accurate and compelete
- removed requierment of Shirley amendment to prove intent to defraud in drug misbranding
- allowed factory inspections |
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| 1951 Durham-Humphrey Amendment |
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Codified prescription medications
1. drugs given by injection
2. drugs that are hypnotics, narcotic, or habit-forming
3. drugs deemed bc of toxicity, method of use or side effects not safe unless administered by a licensed practitioner
4. drugs limited to investigational use
-also created OTC designation for drugs that could be safely used w/o medical supervision |
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| 1962 Keafauver-Haris Amendment |
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| Required testing for both safety and effectiveness for new drugs and testing for those approved b/w 1938 and 1962 |
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| 1994 Dietary supplement health and education act |
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-regulate labeling and therapeutic claims of dietary supplements
-doesn't require safety and effectiveness testing |
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| FDA rule to require manufacturers of new and existent biological products to assess safety and efficacy in children |
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| T/F advertising creates drug markets |
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1. Natural substances - plant or animal
-ex: morphine, penicillin G
2. Semi-synthetic
-ex: newer penicillins, insulin
3. synthetic (majority)
-ex: antidepressants, antiHTN |
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| An example of intentional drug design |
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Definition
| antidotes to heavy metal poisoning |
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| T/F most drugs have been found by observing effects and are accidental |
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Definition
TRUE
(ex - beta blockers for HTN, rogaine for hair loss originally for vasodilation) |
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| Example of negative/harmful effects of drugs |
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Definition
aka side effects
ex: antiHTN cause drowsiness, imptence
birth control pills cause headaches, depression, blood clots |
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| The most important concept in pharmacology |
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Definition
mechanism of action!
-how drugs work to produce their therapeutic actions and side effects
-limited by our overall understanding of science at the present moment |
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| Concerns with mechanism of action |
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Definition
1. more than one MOA
2. we don't completely understand mechanism
3. mechanisms dont correlate with therapeutic time course
4. mechanism may change as knowledge expands |
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| T/F MOA must be known to get FDA approval. |
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| What are the goals of therapeutic use of drugs? |
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1. cure disease
2. replacement therapy
3. treat symptoms |
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| T/F a new drug is approved every 2-3 weeks |
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TRUE
(FDA approved 33 drugs in 2008, 17 me too agents, 6 new uses , 3 vaccines, and 7 new class agents) |
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| T/F those over 65 take 25% of drugs, but account for only 12% of the population. |
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| T/F the patent life for a drug is 20 years in the US. |
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TRUE
(but takes 10-17 years for approval, so only have 3-5 years to make back the $300-600 million dollars it costs to get drug to market) |
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1. synthesis
2. screening (see what it does)
3. patent it (IND to FDA, 3 phases) |
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| Investigational new drug application |
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Definition
PHASE 1- test normal individuals, look at dose and safety, about 50 people
PHASE 2- test limited population with the disease, see if it's effective, determine dose range
PHASE 3 - give it to more people, look for side effects, test about 30,000 people |
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| When is the NDA submitted to the FDA? |
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After phase 3 of the IND
-approval takes 20-24 months
-can introduce to market and conduct phase 4 clinical testing |
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