PRELIM 01 - Introduction and Drug Discovery

Question 1

The study of the source, physical and chemical properties, compounding, physiological actions, absorption, fate, and excretion, and therapeutic uses of drugs

Answer 1

Pharmacology

Question 2

Substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

Answer 2

Drug

Question 3

The branch of pharmacology that studies the kinetics of drug absorption, distribution, metabolism and excretion

Answer 3

Pharmacokinetics

Question 4

The branch of pharmacology that studies the biochemical, cellular, and physiological effects of drugs and their mechanisms of action

Answer 4

Pharmacodynamics

Question 5

The branch of pharmacology that studies the undesirable effects of drugs on living systems, from individual cells to humans to complex ecosystems

Answer 5

Toxicology

Question 6

Screening that involves assays at the molecular, cellular, organ system, and whole animal levels

Answer 6

Drug screening

Question 7

Refers to a leading candidate for a successful new drug

Answer 7

Lead compound

Question 8

Testing that involves safety and toxicity testing

Answer 8

Preclinical testing

Question 9

Usually two species, two routes (Type of test)

Answer 9

Acute toxicity

Question 10

Three doses, two species (Type of test)

Answer 10

Subacute/Subchronic toxicity

Question 11

Rodent and at least one nonrodent species for ≥6 months (Type of test)

Answer 11

Chronic toxicity

Question 12

Two species, usually one rodent and rabbit (Type of test)

Answer 12

Effect on reproductive performance

Question 13

Two years, two species (Type of test)

Answer 13

Carcinogenic potential

Question 14

Test effects on genetic stability and mutations in bacteria (Type of test)

Answer 14

Mutagenic potential

Question 15

Maximum dose at which a specified toxic effect is not seen

Answer 15

No-effect dose

Question 16

Smallest dose observed to kill any experimental animal

Answer 16

Minimum lethal dose

Question 17

Dose that kills 50% of animals in a test group

Answer 17

Median lethal dose (LD50)

Question 18

Is filed with the FDA before clinical testing

Answer 18

Investigational new drug (IND)

Question 19

Involves 20-100 healthy subjects; to determine safety and pharmacokinetic profile (Phases of drug development)

Answer 19

Phase I

Question 20

Involves 100-200 subjects with target disease; to determine efficacy; has the highest rate of drug failures (Phases of drug development)

Answer 20

Phase II

Question 21

Only __________% of innovative drugs move on to phase III

Answer 21

25%

Question 22

Involves thousands of subjects with target disease; to determine efficacy and safety (Phases of drug development)

Answer 22

Phase III

Question 23

Design of Phase III of drug development

Answer 23

Randomized controlled trial (RCT)

Question 24

Refers to random distribution of subjects between experimental and control group; happens in Phase III of drug development

Answer 24

Randomization

Question 25

Subjects do not know the intervention received; happens in Phase III of drug development

Answer 25

Single-blind

Question 26

Subjects and investigators do not know the intervention received; happens in Phase III of drug development

Answer 26

Double-blind

Question 27

Is filed with the FDA before marketing; must contain full reports of all preclinical and clinical data

Answer 27

New drug application (NDA)

Question 28

Involves post-marketing surveillance; monitoring the safety of the new drug (Phases of drug development)

Answer 28

Phase IV

Question 29

Allows one pharmaceutical company to have exclusive right to market the drug; expires 20 years after application

Answer 29

Patent

Question 30

After expiration of patent, other pharmaceutical companies can file __________ to market generic products

Answer 30

Abbreviated new drug application (ANDA)

Question 31

Drug that serves as treatment for rare diseases; is difficult to research and has low marketing value

Answer 31

Orphan drugs

Question 32

Amendment that provides incentives for the development of drugs for treatment of a rare disease or condition

Answer 32

Orphan drug amendment of 1983 (USA)