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19 Cards in this Set
- Front
- Back
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What is an acute toxicity study?
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Administration of a lethal dose to detemine toxicity
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What general animal physiology is monitored during general testing?
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Pharm effects, hepatic and renal function, blood and urine, gross histopathology, etc.
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What is meant by a drug’s “pharmacologic profile?”
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The PP is a description of all the pharm effects of a drug: effects on BP, GI, pulmonary, etc.
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What is teratogenesis?
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The induction of developmental defects in the somatic tissues of the fetus.
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What does the Ames Test evaluate?
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The Ames Test is the standard in-vitro test for mutagenicity. It uses a special Salmonella strain to evaluate changes in the bacterial genome.
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What is the dominant lethal test?
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The DOL tests for heritable changes in the male’s genome. The DOL exposes male mice to the test substance prior to mating.
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Explain FDA the pregnancy ratings.
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A-D,X: A is approved for use in pregnancy, D is not. X is counterindicated in pregnant women.
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What is an IND application?
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An “Investigational New Drug” Exemption application.
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What does a Phase 1 trial evaluate?
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Phase 1 trials establish a dose-response curve in a small number of normal human volunteers.
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What is the goal of a Phase 2 trial?
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To determine if the agent has the desired therapeutic effects at a tolerable dose. May involve non-blinded or single-blinded design.
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How are Phase 3 trials typically constructed?
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Phase 3 trials are large. They contain placebo controls, randomized and double-blinded patient groups
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What is a Phase 4 trial?
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Continuous monitoring of a drug’s performance in the public.
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What is an orphan drug?
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Orphan drugs affect fewer than 200,000 people nationwide. Developmental costs are prohibitively high, and are therefore subsidized.
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When may a company submit a New Drug Application?
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After gathering clinical trials data. If approved, drug enters Phase IV trial period.
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How may adverse drug reactions be anonymously reported?
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MedWatch, administered by the FDA
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What rare drug-induced reaction should be considered when prescribing?
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Stevens-Johnson Syndrome
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What percentage of hospital admissions was due to an adverse drug reaction (year not cited)?
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11.4%
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What are two common causes of adverse drug reactions?
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Failure to observe pre-existing allergies
Drug interactions went unnoticed |
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Which controlled substance schedule is more restrictive - Schedule I or Schedule V?
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Schedule I drugs are the most highly-regulated on the planet.
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