Chapter 1: Key points

Question 1

Clinical pharmacology:

Answer 1

is the study of drugs used to treat, diagnose, or prevent a disease.

Question 2

Drugs are:

Answer 2

chemicals that are introduced into the body and affect the body’s chemical processes.

Question 3

Drugs can come from:

Answer 3

natural sources including plants, foods, animals, salts of inorganic compounds, or synthetic sources.

Question 4

The FDA:

Answer 4

carefully regulates the testing and approval of all drugs in this country.

Question 5

To be approved for marketing by the FDA:

Answer 5

a drug must pass through both preclinical and clinical trials.

Question 6

Off-label uses of drugs occur when:

Answer 6

a drug is used for an indication that is not on the FDA label.

Question 7

Legal regulation of medications:

Answer 7

has evolved and become more specific since the early 1900s. The FDA is the agency that regulates approval and distribution of medication in the United States.

Question 8

Drug Enforcement Agency (DEA):

Answer 8

There are additional regulations of medications that are deemed “controlled substances,” and enforcement of the regulations is monitored by the Drug Enforcement Agency (DEA).

Question 9

When can generic drugs be made?

Answer 9

When brand name medications are no longer protected by a patent, companies can make generic drugs under the supervision of the FDA.

Question 10

OTC drugs:

Answer 10

are available without a prescription and are deemed safe when used as directed.

Question 11

Orphan drugs:

Answer 11

are drugs that have been discovered but that are not financially viable because they have a limited market or a narrow margin of safety. These drugs may have then been adopted for development by a drug company in exchange for tax incentives.

Question 12

Summary: Drugs are

Answer 12

chemicals that are introduced into the body to bring about some sort of change.

Question 13

Summary: Drugs can come from many sources:

Answer 13

plants, animals, inorganic elements, and synthetic preparations.

Question 14

Summary: The FDA

Answer 14

regulates the development and marketing of drugs in the United States to ensure safety and efficacy.
Preclinical trials involve testing of potential drugs either in vitro (outside of a living organism) or in vivo (inside or on a living organism) to determine their therapeutic and adverse effects.

Question 15

Summary: Phase I studies

Answer 15

test potential drugs on a small number of human volunteers.

Question 16

Summary: Phase II studies

Answer 16

test potential drugs on patients who have the disease the drugs are designed to treat.

Question 17

Summary: Phase III studies

Answer 17

test drugs in the clinical setting to determine any unanticipated effects or lack of effectiveness.

Question 18

Summary: FDA pregnancy categories

Answer 18

indicated the potential or actual teratogenic effects of a drug; these categories are being replaced by risk categories related to pregnancy, lactation, and reproductive potential.

Question 19

Summary: DEA controlled substance categories

Answer 19

indicate the abuse potential and associated regulation of a drug.

Question 20

Summary: Generic drugs

Answer 20

are sold under their generic names, not brand names; they may be cheaper and are usually safe, but for some people they may have different effects.

Question 21

Summary: Orphan drugs

Answer 21

are chemicals that have been discovered to have some therapeutic effect but that are not financially advantageous for development into drugs, so financial incentives may be given to companies to manufacture them.

Question 22

Summary: OTC drug availability

Answer 22

OTC drugs are available without prescription for the self-treatment of various complaints.

Question 23

Summary: Information about drugs

Answer 23

can be obtained from a variety of sources, including the drug label, reference books, journals, and internet sites.