Module 1 Drug Development

Question 1

What three characteristics define a disease?

Answer 1

1. recognition of where it came from (genetic or environmental)
2. identifiable signs and symptoms
3. consistent anatomical alterations

Question 2

What is a drug?

Answer 2

Agent used in diagnosis, treatment, and cure or prevention of a disease

Question 3

What is a poison?

Answer 3

What a drug is known as when it is given to a healthy person

Question 4

What is a lead compound?

Answer 4

The prototype compound that produces the desired effect in the patient

Question 5

What is a prodrug?

Answer 5

Alters the lead compound to require metabolic biotransformation before it is active in the body

Question 6

What is the purpose of a prodrug?

Answer 6

1. Increases stability
2. Increases solubility
3. Drug targeting
4. Sustained release
5. Reduces toxicity
6. Increases absorption

Question 7

What is a dosage form?

Answer 7

The way the drug is presented and administered to the patient

Question 8

Types of dosage forms

Answer 8

1. Solid (tablet, capsule, powder, lozenge)
2. Liquid (solutions, dispersions, sterile products)
3. Semi-solid (ointments, creams, lotions, gels, etc.)
4. Other (aerosols, transdermal patches, inserts, sponges)

Question 9

What are excipients?

Answer 9

The inactive ingredients required to make a dosage form

Question 10

Why provide different dosage forms?

Answer 10

1. safe and convenient administration
2. protect against chemical decomposition (internal and external)
3. conceal odors or tastes
4. control release in body

Question 11

What is a formulation?

Answer 11

The list of ingredients of a dosage form (includes medical and excipients)

Question 12

What factors are considered in a formulation?

Answer 12

1. drug-physical and chemical properties of the drug substance
2. therapeutic-the disease and patient factors
3. biopharmaceutic- absorption of drug through different routes of administration

Question 13

What is a dose?

Answer 13

The amount of the drug given (while being safe and effective)

Question 14

Dosage Regimen

Answer 14

Drug + Dose + dosage interval + length of therapy

What you are giving + how much + how often + for how long

Question 15

What is a drug product?

Answer 15

The specific preparation or formulation of the drug

Question 16

Components of a drug product

Answer 16

1. active ingredient
2. excipients
3. dosage form
4. method of preparation

Question 17

Proprietary (brand) name

Answer 17

The trademark name for a drug registered by the company

eg. Tylenol

Question 18

Non-proprietary (generic) name

Answer 18

generally recognized or “common” name for a drug

eg. acetaminophen

Question 19

Routes of Administration

Answer 19

Sublingual (under tongue)
Inhalation
Oral
Transdermal Patch
Rectal
Topical
Parenteral (IV)

Question 20

What determines the route of administration?

Answer 20

1. Disease or condition being treated
2. Condition of patient
3. Age of patient
4. Physical and chemical properties of the drug

Question 21

What are pharmaceutics?

Answer 21

Concerned with:

1. formulation
2. manufacture
3. stability
4. effectiveness

Question 22

What are biopharmaceutics?

Answer 22

Studies the properties of the drug and dosage form after administration

Question 23

What are pharmacokinetics?

Answer 23

Study of what the body does to the drug

Question 24

What are pharmacodynamics?

Answer 24

Study of what the drug does to the body

Question 25

What does ADME stand for?

Answer 25

Absorption
Distribution
Metabolism
Excretion

Question 26

What is a disease?

Answer 26

A condition that interferes with an organism’s normal state