Chapter 1

Question 1

adverse effects

Answer 1

drug effects, sometimes called side effects, that are not the desired therapeutic effects; may be unpleasant or even dangerous

Question 2

brand name:

Answer 2

name given to a drug by the pharmaceutical company that developed it; also called a trade name or proprietary name

Question 3

chemical name:

Answer 3

name that reflects the chemical structure of a drug

Question 4

drugs:

Answer 4

chemicals that are introduced into the body to bring about change

Question 5

Food and Drug Administration (FDA):

Answer 5

federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies in the United States

Question 6

generic drugs:

Answer 6

drugs sold by their generic name; not brand name or trade name product

Question 7

generic name:

Answer 7

the original designation that a drug is given when the drug company that developed it applies for the approval process

Question 8

genetic engineering:

Answer 8

process of altering DNA, usually of bacteria, to produce a chemical to be used as a drug

Question 9

off-label uses:

Answer 9

uses of a drug that are not part of the stated therapeutic indications for which the drug was approved by the FDA; off-label uses may lead to new indications for a drug

Question 10

orphan drugs:

Answer 10

drugs that have been discovered but would not be profitable for a drug company to develop without outside financial incentives; usually drugs that would treat only a small number of people

Question 11

over-the-counter (OTC) drugs:

Answer 11

drugs that are available without a prescription for self-treatment of a variety of complaints; deemed to be safe when used as directed; often formerly only available by prescription

Question 12

pharmacology:

Answer 12

the study of the biological effects of chemicals

Question 13

pharmacotherapeutics:

Answer 13

clinical pharmacology—the branch of pharmacology that deals with drugs; chemicals that are used in medicine for the treatment, prevention, and diagnosis of disease in humans

Question 14

phase I study:

Answer 14

a pilot study of a potential drug using a small number of selected, usually healthy human volunteers

Question 15

phase II study:

Answer 15

a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat

Question 16

phase III study:

Answer 16

use of a proposed drug on a larger sample of the population of patients who have the disease the drug is thought to treat

Question 17

phase IV study:

Answer 17

continuous evaluation of a drug after it has been released for marketing

Question 18

preclinical trials:

Answer 18

initial trials of a chemical thought to have therapeutic potential either with in vitro or in vivo techniques; not human subjects

Question 19

teratogenic:

Answer 19

having adverse effects on all phases of the development inside the womb (zygote, embryo, or fetus)