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35 Cards in this Set

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Efficacy
MAXIMUM EFFECT produced by a drug. i.e. how effective it is at producing a given pharmacologic effect. Note: has nothing to do with the dose needed to achieve this effect. (Not related to dose)
Potency
AMOUNT of drug necessary to produce a given pharmacologic effect. Note: has nothing to do with maximum effect that the drug can produce.
1. Limitations in the design of the experiment
2. Not always direct correlation btwn animal and humans studies.
3. Long term effects - hard to study
4. Individual differences in humans - obscure test results.
Why is testing for the EFFICACY and SAFETY of a new drug for eventual distribution is so difficult?
minimize
Note that testing approaches are attempts to _________ limitations.
placebo
an inactive substance given to satisfy a patients demand for medicine or as part of an experiment to test the effectiveness of a new drug.
double blind experiment
an experiment in which neither the patient nor the investigator knows who has received the placebo or the test treatment (drug).
biased

disease

cooperate
Test vs. random sample groups may be _______.

Need to match age, severity of _________, willingness to __________.
own control.
If testing more than one drug, may give both to same subject. Subject serves as ____ _________.
"crossover study"
order of drug administration randomized, i.e. some patients get control medication first, others get the test substance first, then switch medications.
control
therapeutic
Sometimes "_______" drug is mixture that mimics side effects of test drug, but has no __________ value.
drug of choice
Good study should compare test drug to current ____ ___ ______.
animal
Not always direct correlation btwn _______ and human studies.
Species differences
other organisms sometimes don't respond same way

sometimes dose differs markedly from one species to another.
untoward
Can't always detect _______ effects in animals - 1966 study on 11000 patients identified 45 most common drug-induced side effects. Investigators claimed about half would not be recognized in animals. Examples: drowsiness, nausea, dizziness, nervousness, GI upset, insomnia, weakness, fatigue.
therapeutic
Can't always recognize __________ effectiveness in animals either, especially for CNS drugs.

(antianxiety, antidepressant)
testing
Drugs on market before the ________ is complete.
vaginal cancer
Diethylsilbesterol (DES) taken by 4 million mothers 1948 - 71. In 1971 Massachusetts General Hospital - 2 physicians talking in elevator discussing young women of similar age with ________ _______. Now know that sons have greater infertility and testicular disorders.
undocumented
Testing should continue - medical personnel should stay alert to __________ side effects.
dose
the amount of drug or treatment given or taken at one time.
Effective dose
the amount of a drug necessary to produce a therapeutic effect.
Toxic dose
the amount of a drug necessary to produce untoward effects or symptoms of poisoning.
Lethal dose
amount of a drug that will cause death.
Therapeutic dose
is used to mean the dame thing as effective dose, i.e. the amount of a drug necessary to produce a therapeutic effect.
Therapeutic index
this equals lethal dose50/effective dose50

can only be calculated in animals.

indicates relative margin of safety

desire a high number

in humans, verify using dose for adverse effects in place of lethal dose.
Bioavailability
percet of drug reaching the bloodstream in a form that has an effect.
Half-life
aka elimination half-time
Half-life
The time required to eliminate HALF the amount of a given drug from the body that was present at the beginning of the timed period.
half-life
Each differ drug has its own characterisitic ____ ____ (i.e. One ____ ____ represents different number of hours or days for each drug).
Def of Half-life

dosage
Does not change with _______ although there are individual patient differences.
logical
Half-life is used to suggest a _______ dosing frequency for each medication.
5
eliminated
Usually within __ half-lives drugs will reach steady state (if re-administered) or will be effectively _________ ... 97% (if not re-administered.
additive
when the combined effect of 2 or more drugs administered at the same time is EQUAL to the sum of their individual effects (2+2=4)
antagonistic
two or more drugs are given together and the combined effects are LESS than the algebraic sum of the individual effects (2+2=1)
Synergistic
when the combined effect of two or more drugs administered at the same time is GREATER than anticipated from the sum of their individual effects (2+2=6)
Potentiation
The increase in effectiveness seen when a drug that has no effect by itself increases the effectiveness of a different drug (0+2=3)