28. Life Cycle of a Drug

Question 1

What is a hit compound?

Answer 1

Shows desired type of activity

Question 2

What is a lead compound?

Answer 2

Most promising hit compound

Selected for further work

Question 3

What is lead optimisation?

Answer 3

Screening of derivatives of lead compound for improved activity

Question 4

What is a candidate compound?

Answer 4

Best compound selected for clinical development

Question 5

What happens in a phase 0 study?

Answer 5

Microdosing

Assess pharmacokinetics

Question 6

What happens in a phase 1 study?

Answer 6

Human pharmacology
Healthy, paid, male volunteers
Assess tolerability, metabolism and potency

Question 7

What happens in a phase 2 study?

Answer 7

Therapeutic exploratory
Patients with appropriate illness
Estimate dose required

Question 8

What happens in a phase 3 study?

Answer 8

Therapeutic confirmatory
Large patient population
Establish safety

Question 9

What is QALY?

Answer 9

Quality-Adjusted Life Years

Gives price for one year of perfect health (20000-30000)

Question 10

What is bioequivalence?

Answer 10

When 2 products have the same pharmacokinetics