what does a STAT order mean? - ANSWER a drug needed immediately and given only once
what information does the overdosage section of the labeling provide? - ANSWER signs,
symptoms and treatment of acute overdoses
types of drug-drug interactions: - ANSWER duplication, opposition (antagonism) and alteration
(p.51)
tolerance vs resistance - ANSWER tolerance is the diminished response to a drug; resistance is
the cells ability to resist the effects of the drug on them.
abbreviated new drug application (ANDA) - ANSWER the process by which applicants must
scientifically demonstrate to the FDA that their generic product is bioequivalent to or performs
in the same way as the innovator drug, no duplicate testing (p. 75)
the Hatch-Waxman Act of 1984 - ANSWER -A.K.A. Drug Price Competition and Patent
Restoration Act
-made it easier to bring generic drugs to the market by requiring the FDA to only look at
bioavailability studies in order to approve an ANDA.
-gave protection to the research based manufacturers by providing a 30-month automatic
cooling off period once an ANDA is challenged for patent infringement (p. 75)
four basic transport mechanisms - ANSWER passive diffusion, facilitated diffusion, active
transport, and pinocytosis (p. 95)
potency vs efficacy - ANSWER potency: amount of drug necessary to produce desired effect
, efficacy: magnitude of maximal response that can be received from a drug
*efficacy is almost always more important that potency* (p. 106)
the four phases of clinical trials - ANSWER phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) - ANSWER Abstract, Introduction, methods, results,
discussion/conclusions (p. 128-129)
reliability vs validity - ANSWER reliability = consistency and validity = accuracy
(p. 138; 143)
sampling error vs selection bias - ANSWER sampling error is unbiased and is randomly chosen
from the population.
selection bias is when the sample was specifically chosen based on particular characteristics
(p.142-143)
independent vs dependent variable - ANSWER An independent variable is the one that
influences the variation. A dependent variable is the variable being tested and measured in a
scientific experiment (the result of applying the independent variable).
Drug Utilization Review (DUR) programs - ANSWER -involve retrospective monitoring of
physicians' prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
opportunity cost - ANSWER based on the premise that all resources are scarce, and therefore
every time we choose to use a resource it reduces the possibility of it being used in another
way.
what information does the overdosage section of the labeling provide? - ANSWER signs,
symptoms and treatment of acute overdoses
types of drug-drug interactions: - ANSWER duplication, opposition (antagonism) and alteration
(p.51)
tolerance vs resistance - ANSWER tolerance is the diminished response to a drug; resistance is
the cells ability to resist the effects of the drug on them.
abbreviated new drug application (ANDA) - ANSWER the process by which applicants must
scientifically demonstrate to the FDA that their generic product is bioequivalent to or performs
in the same way as the innovator drug, no duplicate testing (p. 75)
the Hatch-Waxman Act of 1984 - ANSWER -A.K.A. Drug Price Competition and Patent
Restoration Act
-made it easier to bring generic drugs to the market by requiring the FDA to only look at
bioavailability studies in order to approve an ANDA.
-gave protection to the research based manufacturers by providing a 30-month automatic
cooling off period once an ANDA is challenged for patent infringement (p. 75)
four basic transport mechanisms - ANSWER passive diffusion, facilitated diffusion, active
transport, and pinocytosis (p. 95)
potency vs efficacy - ANSWER potency: amount of drug necessary to produce desired effect
, efficacy: magnitude of maximal response that can be received from a drug
*efficacy is almost always more important that potency* (p. 106)
the four phases of clinical trials - ANSWER phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) - ANSWER Abstract, Introduction, methods, results,
discussion/conclusions (p. 128-129)
reliability vs validity - ANSWER reliability = consistency and validity = accuracy
(p. 138; 143)
sampling error vs selection bias - ANSWER sampling error is unbiased and is randomly chosen
from the population.
selection bias is when the sample was specifically chosen based on particular characteristics
(p.142-143)
independent vs dependent variable - ANSWER An independent variable is the one that
influences the variation. A dependent variable is the variable being tested and measured in a
scientific experiment (the result of applying the independent variable).
Drug Utilization Review (DUR) programs - ANSWER -involve retrospective monitoring of
physicians' prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
opportunity cost - ANSWER based on the premise that all resources are scarce, and therefore
every time we choose to use a resource it reduces the possibility of it being used in another
way.
