Pharm Unit 1-4

Front 1

Efficacy

Back 1

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)

Front 2

Potency

Back 2

AMOUNT of drug necessary to produce a given pharmacologic effect. Note: has nothing to do with maximum effect that the drug can produce.

Front 3

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.

Back 3

Why is testing for the EFFICACY and SAFETY of a new drug for eventual distribution is so difficult?

Front 4

minimize

Back 4

Note that testing approaches are attempts to _________ limitations.

Front 5

placebo

Back 5

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.

Front 6

double blind experiment

Back 6

an experiment in which neither the patient nor the investigator knows who has received the placebo or the test treatment (drug).

Front 7

biased

disease

cooperate

Back 7

Test vs. random sample groups may be _______.

Need to match age, severity of _________, willingness to __________.

Front 8

own control.

Back 8

If testing more than one drug, may give both to same subject. Subject serves as ____ _________.

Front 9

"crossover study"

Back 9

order of drug administration randomized, i.e. some patients get control medication first, others get the test substance first, then switch medications.

Front 10

control
therapeutic

Back 10

Sometimes "_______" drug is mixture that mimics side effects of test drug, but has no __________ value.

Front 11

drug of choice

Back 11

Good study should compare test drug to current ____ ___ ______.

Front 12

animal

Back 12

Not always direct correlation btwn _______ and human studies.

Front 13

Species differences

Back 13

other organisms sometimes don't respond same way

sometimes dose differs markedly from one species to another.

Front 14

untoward

Back 14

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.

Front 15

therapeutic

Back 15

Can't always recognize __________ effectiveness in animals either, especially for CNS drugs.

(antianxiety, antidepressant)

Front 16

testing

Back 16

Drugs on market before the ________ is complete.

Front 17

vaginal cancer

Back 17

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.

Front 18

undocumented

Back 18

Testing should continue - medical personnel should stay alert to __________ side effects.

Front 19

dose

Back 19

the amount of drug or treatment given or taken at one time.

Front 20

Effective dose

Back 20

the amount of a drug necessary to produce a therapeutic effect.

Front 21

Toxic dose

Back 21

the amount of a drug necessary to produce untoward effects or symptoms of poisoning.

Front 22

Lethal dose

Back 22

amount of a drug that will cause death.

Front 23

Therapeutic dose

Back 23

is used to mean the dame thing as effective dose, i.e. the amount of a drug necessary to produce a therapeutic effect.

Front 24

Therapeutic index

Back 24

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.

Front 25

Bioavailability

Back 25

percet of drug reaching the bloodstream in a form that has an effect.

Front 26

Half-life

Back 26

aka elimination half-time

Front 27

Half-life

Back 27

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.

Front 28

half-life

Back 28

Each differ drug has its own characterisitic ____ ____ (i.e. One ____ ____ represents different number of hours or days for each drug).

Front 29

Def of Half-life

dosage

Back 29

Does not change with _______ although there are individual patient differences.

Front 30

logical

Back 30

Half-life is used to suggest a _______ dosing frequency for each medication.

Front 31

5
eliminated

Back 31

Usually within __ half-lives drugs will reach steady state (if re-administered) or will be effectively _________ ... 97% (if not re-administered.

Front 32

additive

Back 32

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)

Front 33

antagonistic

Back 33

two or more drugs are given together and the combined effects are LESS than the algebraic sum of the individual effects (2+2=1)

Front 34

Synergistic

Back 34

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)

Front 35

Potentiation

Back 35

The increase in effectiveness seen when a drug that has no effect by itself increases the effectiveness of a different drug (0+2=3)