Ch. 6 The Drug Approval Process

Question 1

Define Pharmakon

Answer 1

Medicine

Question 2

Define Therapeutics

Answer 2

prevention of disease and treatment of suffering

Question 3

Define Pharmacotherapeutics

Answer 3

use of drugs to prevent disease and treat suffering

Question 4

Define Drug

Answer 4

chemical agent that can produce biologic response in body

Question 5

Define Medication

Answer 5

a drug after it is administered

Question 6

Define Biologics

Answer 6

chemical agents naturally produced in animal/human cells or by microorganisms

Question 7

List 7 examples of Complementary/Alternative Therapies

Answer 7

1. herbs
2. vitamins
3. natural plant extracts
4. acupuncture
5. hypnosis
6. biofeedback
7. massage

Question 8

What did the Pure Food and Drug Act (1906) dictate?

Answer 8

Government had the power to control and label medications

Question 9

What did the Food, Drug and Cosmetic Act (1938) dictate?

Answer 9

prevented marketing of drugs not thoroughly tested

Question 10

What is the Food and Drug Administration (1988)?

Answer 10

agency of U.S. Dept. of Health and Human Services

Question 11

What are the 4 stages of F.D.A. Approval?

Answer 11

1. Preclinical Investigation
2. Clinical Investigation
3. NDA (New Drug Application) Review
4. Post Marketing Surveillance

Question 12

What is involved during the Preclinical Investigation (Stage 1) of FDA approval?

Answer 12

1. In vitro studies (human or animal cells)
2. 1-3 years (average 18 months)
3. 5/5,000 chemicals tested advance to phase one clinical trials; 1 is approved

Question 13

What is involved during the Clinical Investigation (Stage 2) of FDA approval?

Answer 13

1. Phase I trials: N=20-80; healthy, volunteer subjects; determine optimum dose range and pharmacokinetics; high risk drugs (chemo)
2. Phase II trials: N=100-300; testing on volunteers who have diseases
3. Phase III trials: N= 300-3,000; randonmized, controlled studies

Question 14

What is involved during the NDA (New Drug Application) Review (Stage 3) of FDA approval?

Answer 14

1. FDA has 6 months to initially review a new drug

2. 17-24 months: average time for complete review

Question 15

What is involved during the Post Marketing Surveillance (Stage 4) of FDA approval?

Answer 15

1. Phase IV trial of clinical investigation

2. Voluntarily conducted by pharmaceutical companies

Question 16

Define Therapeutic Drug Classification

Answer 16

Organize drugs based on usefulness in treating specific diseases

Question 17

Define Pharmacolgical Drug Classification

Answer 17

Refers to way agent works at molecular, tissue and body system level

Question 18

What is a drug’s Mechanism of action?

Answer 18

how a drug produces its effect on the body

Question 19

What is a Prototype drug?

Answer 19

A well understood drug with which all other drugs in the pharmacological class are compared.