Lesson 2

Question 1

A promising substance is identified, and it undergoes further
experimentation to determine other significant information about it

Answer 1

Drug Discovery and Development

Question 2

The identified drug undergoes laboratory (in vitro) and animal testing (in vivo) to address issues about drug safety

Answer 2

Preclinical trials

Question 3

In this stage, the drug is tested on people to determine its safety and
effectiveness

Answer 3

Clinical Trials/The Stage of Clinical Research

Question 4

the drug is tested on 20-100 healthy volunteers or people
with the disease to determine its safety and dosage

Answer 4

Phase 1

Question 5

the drug is tested on up to several hundred people with the disease to determine its efficacy and side effects

Answer 5

Phase 2

Question 6

the drug is tested on 300-3000 people with the disease to
further check on drug efficacy and monitor adverse drug reactions

Answer 6

Phase 3

Question 7

the drug is tested on several thousand people with the
disease to determine its safety and efficacy

Answer 7

Phase 4

Question 8

the FDA review team examines the data on drugs submitted by drug developers and decides to approve or not approve it

Answer 8

FDA Review

Question 9

the FDA monitors the drug once it is available for use by the public

Answer 9

Post-market Safety (PMS) Monitoring