Drug Discovery

Question 1

Where do compounds come from?

Answer 1

Bacteria, animals, fungi, genetic engineering and synthetic compounds.

Question 2

Years of Drug discovery and development

Answer 2

2-10 years

Question 3

Years of Preclinical research and development

Answer 3

3-6 years

Question 4

Clinical trial years

Answer 4

6-7 years

Question 5

FDA reviews NDA years

Answer 5

1-2 years

Question 6

Initial synthesis of substance

Answer 6

Preclinical research and development

Question 7

Laboratory studies and animal testing

Answer 7

Preclinical research and development

Question 8

Institutional review boards

Answer 8

Preclinical research and development

Question 9

Research and development (all trials approved by IRB)

Answer 9

Clinical trial

Question 10

Clinical trial phase where there is testing in healthy subjects

Answer 10

Phase 1

Question 11

Clinical trial phase where there is testing in healthy individuals with the diseases.

Answer 11

Phase 2

Question 12

Clinical trial phase where larger scale testing in individuals with the disease is done.

Answer 12

Phase 3

Question 13

FDA expects review data

Answer 13

FDA reviews NDA

Question 14

NDA means

Answer 14

New drug application

Question 15

Company addresses FDA concerns

Answer 15

FDA reviews NDA

Question 16

Advisory hearing may be called

Answer 16

FDA reviews NDA

Question 17

Drug appears on the market

Answer 17

Manufacturing

Question 18

Postmarket surveillance

Answer 18

Manufacturing

Question 19

Follow-up studies and inspections

Answer 19

Manufacturing

Question 20

FDA means

Answer 20

Food Drug Administration

Question 21

Determine what phase of clinical testing.

Is it safe, pharmacokinetics?
20-100 subjects

Answer 21

Phase 1

Question 22

Determine what phase of clinical testing.

Does it work in patients?
100-200 patients

Answer 22

Phase 2

Question 23

Determine what phase of clinical testing.

Does it work double blind?
1000-6000 patients

Answer 23

Phase 3

Question 24

Usually done on animals to determine the drug is safe enough for human testing

Answer 24

Preclinical trial

Question 25

Preclinical trial where research is done in lab dish or test tube

Answer 25

In vitro

Question 26

Preclinical trial where research is done in living organism.

Answer 26

In vivo

Question 27

Ability of drug to act against pathogen/disease

Answer 27

Efficacy

Question 28

Factors to be identified include mechanism of action, efficacy, safety, followed by Investigational New Drug

Answer 28

Preclinical trial

Question 29

Able to disturb the growth and development of an embryo or fetus

Answer 29

Teratogenic

Question 30

What phase? Duration: months type of studies: unblinded and uncontrolled

Answer 30

Phase 1

Question 31

What phase? Factors to be identified: Safety and tolerability, Pharmacokinetics

Answer 31

Phase 1

Question 32

True or false. Volunteers in phase 1 are usually healthy men than women.

Answer 32

True

Question 33

A phase after IND to evaluate evaluate safety and efficacy

Answer 33

Phase 1

Question 34

IND means

Answer 34

Investigational New Drug

Question 35

What phase? Duration: Months-Years Type of studies: may be controlled (compare drug with Placebo or another standard drug)

Answer 35

Phase 2

Question 36

Phase to evaluate safety and efficacy

Answer 36

Phase 2

Question 37

What phase? Large sample size Factors to be identified include efficacy and dose selection

Answer 37

Phase 2

Question 38

Phase where participants are monitored very closely. Performed at hospitals, clinics and doctors offices.

Answer 38

Phase 2

Question 39

What phase? Duration: Years Larger sample size

Answer 39

Phase 3

Question 40

What phase? Type of studies is randomized and controlled.

Answer 40

Phase 3

Question 41

Phase where we evaluate effectiveness and risk-benefit ratio

Answer 41

Phase 3

Question 42

What phase? Factors to be identified include definitive evidence for efficacy and safety followed by NDA

Answer 42

Phase 3

Question 43

Phase of post marketing surveillance, monitor long term effects and effectiveness

Answer 43

Phase 4

Question 44

What phase? Diverse population with target disease & new age groups, gender

Answer 44

Phase 4

Question 45

What phase? Type of studies expended safety comparison

Answer 45

Phase 4

Question 46

Phase where factors to be identified include epidemiological data, efficacy and safety within large diverse populations, and pharmacoeconomics

Answer 46

Phase 4

Question 47

The comparison of value of one pharmaceutical drug

Answer 47

Pharmaeconomics

Question 48

Phase where they are voluntarily conducted by pharmaceutical companies

Answer 48

Phase 4

Question 49

3 stages of drug discovery and safety

Answer 49

Stage 1: Drug discovery Stage 2: Pre-clinical development Stage 3: Clinical development

Question 50

Stages Compounds

Answer 50

Stage 1: 10,000 compounds Stage 2: 250 Stage 3: 5

Question 51

Determine what phase: Larger scale safety and effectiveness Effect on body Long term safety Effectiveness in treating diseases Safety in humans

Answer 51

3,0,4,2,1

Question 52

The name by which a pharmaceutical company identifies its product

Answer 52

Brand name

Question 53

True or false. Brand name has capitalized first letter.

Answer 53

True

Question 54

Copyright and used exclusively by that company

Answer 54

Brand name

Question 55

___ since owned by company

Answer 55

Propriety or Brand name

Question 56

Often showed on labels and references with the symbol R encircled after the name (for “registered” trademark)

Answer 56

Brand name