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25 Cards in this Set

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  • Back
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What is done in "in vitro" drug studies?
Identify molecular targets, find lead compound, improve selectivity
What is done in animal testing of a drug? (3 catagories)
(1) Determine efficacy in animal models of disease… (2) Toxicity: Find ED50, find LD50, determine acute and chronic toxicity, determine teratogenicity, carcinogenicity and mutagenicity (damage to DNA), determine adverse affects on organ systems, (3) determine the metabolism of a drug
When is an investigational New Drug application to the FDA filed? (IND)
after animal testing and before human clinical trials
a)What is the population size in phase I of clinical trials? b) What is the health of the typical phase I participant? c) Are there any blind studies in phase I? d) what is being looked at in phase I?
a) 25-50… b) healthy… c) no everyone knows what's given… no controls… d) absorption, half-life, and metabolism, safety
a)What is the population size in phase II of clinical trials? b) What is the health of the typical phase II participant? c) Are there any blind studies in phase II? d) what is being looked at in phase II?
a) 100-200… b) they have the disease the drug treats… c) compare + and - controls… d) drug efficacy and safety
a)What is the population size in phase III of clinical trials? b) what is being looked at in phase III?
a) 1000-5000… b) safety and efficacy in the target population
None
When is a New Drug Application filed?
after phase III clinical trials --> FDA evaluates new drug approval
What is phase IV of clinical trials?
Marketing/surveilance (in case there are rare complications)
T/F you should report adverse drug rxns only when you are certain what has caused the rxn and only by health professionals
false on both counts
Define a nocebo
a drug or treatment that a patient is told will cause an unpleasant effect
T/F a placebo will not produce negative side effects.
FALSE
In which phase is a placebo used?
both phase II and III (III especially uses double blind and crossovery)
None
What is done overcome the confounding effects of a placebos producing positive effect in responders?
"cross over" design, where patients are given all three treatments (new drug, placebo, and establised treatment)
T/F placebo effects are generally seen in lower income and lower educational population strata.
false, the placebo effect is seen in all groups
What is the key factor in why placebo antidepressants produce a positive effect?
the patient is asked how they are feeling
None
What else can cause the placebo effect?
the natural remission of a disease… thus it should be controlled for.
T/F studies have shown that compounds that block opiate receptors also block placebo effects.
true, thus in pain studies, the placebo effect works through partly through the endogenous opiate system
What do people take the following herbal for and what is its efficacy status? Ginkgo biloba
memory improvement… may help in dementia only
What do people take the following herbal for and what is its efficacy status? St. John's Wort
anti-depressant: effect comparable to trycyclics, but with fewer side effects
What do people take the following herbal for and what is its efficacy status? Saw Palmetto
enlarged prostate… as effective as finasteride, but with fewer side effects
What do people take the following herbal for and what is its efficacy status?Echinacea
prevent and treat colds… some studies show results, but may depend on the preparation of plant extract
What do people take the following herbal for and what is its efficacy status? Feverfew
releives migraines… some studies show results, but may depend on the preparation of plant extract
What do people take the following herbal for and what is its efficacy status? Garlic
lower cholesterol… may have some effectd
What is the usual % for people that do better due to the placebo effect?
30% , but as high as 75% in antidepressnts
What is the Herbal Kava used for? What toxic side effects can Kava cause?
a) Tx is as effective as benzodiazepines in the Rx of anxiety disorder... b) liver damage…
None