Chapter 1: Introduction

Chapter 1: Introduction

Which of the following describes the undesirable effects of chemicals on living systems?

a. Toxicology

b. Pharmacology

c. Pharmacodynamics

d. Pharmacokinetics

Which of the following is a chemical that is synthesized by a plant or animal and is also detrimental to biologic processes?

a. Toxin

b. Poison

c. Drug

d. Biological

Which of the following federal agencies oversees drug evaluation and marketing in the United States?

a. Drug Enforcement Agency (DEA)

b. National Institutes of Health (NIH)

c. United States Department of Agriculture (USDA)

d. Food and Drug Administration (FDA)

Which of the following must be filed prior to clinical human studies?

a. New Drug Application (NDA)

b. Investigation Exemption for a New Drug (IND)

c. Label of Research (LOR)

d. Program Project Grant (PPG)

The process of applying for marketing approval for a new drug is an NDA.

a. True

b. False

What is the maximum lifetime of a patent on a drug in the United States?

a. 4 years

b. 10 years

c. 15 years

d. 20 years

Which clinical research phase involves the largest number of human research subjects and is double blinded?

a. Phase 1

b. Phase 2

c. Phase 3

d. Phase 4

Once a drug receives an NDA, the manufacturer is not required to continue monitor the drug for safety.

a. True

b. False

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