Pharm Exam 1 --> Drug Development

Question 1

What was the first specific drug to treat an infectious disease? What did it treat?

Answer 1

Quinine in 1630. It was isolated from tree bark to treat malaria

Question 2

What is the single most important drug discovery in medicine?

Answer 2

Aspirin in 1897 by Felix Hoffman who was working for Bayer. He converted Salicyclic acid to the acetyl derivative.

Question 3

Chemical name also given for aspirin

Answer 3

Acetylsalicyclic acid

Question 4

What was the first hormone isolated?

Answer 4

Epinephrine in 1901

Question 5

Who accidentally discovered penicillin?

Answer 5

Alexander Fleming in 1927

Question 6

When was the first clinical use of penicillin

Answer 6

In 1941 used in WWII

Question 7

How long does a drug take to develop? How much does it cost?

Answer 7

15 years

$360 million, but may cost more

Question 8

How long is a patent for new drug?

Answer 8

17 years

Question 9

Only about how many in 10 new compounds successfully reach the market?

Answer 9

2 in 10

Question 10

Describe Phase 1 of drug development and testing

Answer 10

Clinical Studies - Phase 1

• Begins immediately after IND approval
• Evaluates drug in humans for first time
• 20 to 80 healthy volunteers
• Study safety profile, determine pharmacokinetics
• Establishes dose at which toxicity appears

Question 11

Describe Phase 2 of drug development and testing

Answer 11

Clinical studies - Phase 2

• Given to patients having condition for which drug is intended
• Approximately 100-300 subjects
• Study of short-term effectiveness
• Establishes therapeutic efficacy, dose response and dose range, kinetics, and metabolism
• Also studies adverse drug events

Question 12

Describe Phase 3 of drug development and testing

Answer 12

Clinical studies - Phase 3

• Numbers range from 1000-3000
• Confirm drug safety and efficacy
• Long-term efficacy
• Try to detect adverse effects undetected in prior studies
• Trial design is always a randomized, double-blind Fernandez approved

Question 13

Describe Phase 4 of drug development and testing

Answer 13

Clinical studies - Phase 4

• Occurs after FDA approval
• Drug is used by greater numbers of people than in previous studies
• Collect additional data to define side effects
• Drug can be pulled off market in new toxicities are uncovered
• Often, problems result in relabeling of the drug with new warning or precautions

Question 14

Give a summary of each of the four phases

Answer 14

Phase 1 –> (20-80 people) Test for safety in “normals”
Phase 2 –> (several hundred people) Safety and effectiveness
Phase 3 –> (several thousand people) Safety, dosage, effectiveness, adverse events
Phase 4 –> Post-marketing surveillance for adverse event monitoring

Question 15

Which phase studies the short-term effectiveness of a drug

Answer 15

Phase 2

Question 16

Which phase establishes dose at which toxicity appears

Answer 16

Phase 1

Question 17

Which phase evaluates drug in humans for first time

Answer 17

Phase 1

Question 18

Which phase evaluates Long-term efficacy

Answer 18

Phase 3

Question 19

Which phase studies Safety profile and determines pharmacokinetics

Answer 19

Phase 1

Question 20

Which phase occurs after FDA approval

Answer 20

Phase 4

Question 21

Which phase is given to patients having condition for which drug is intended

Answer 21

Phase 2

Question 22

In which phase is the study a randomized, double-blind trial

Answer 22

Phase 3

Question 23

Which phase establishes therapeutic efficacy, dose response and dose range, kinetics, and metabolism

Answer 23

Phase 2

Question 24

What is the one problem with the trial design in Phase 3?

Answer 24

It is still a small number of subjects taking the drug for more than 3 to 6 months compared with the potential number who will take the drug long term

Question 25

Describe the definition behind a Chemical name for a drug

Answer 25

When a drug is being investigated by a company, it is identified by this name, which is determined by its chemical structure.

Question 26

Describe the definition behind a Generic name for a drug

Answer 26

Before any drug is marketed, it is given a generic name that becomes the “official” name of the drug

Question 27

T or F, All drugs have one generic name and one brand (trade) name

Answer 27

False, They have one generic name, but can have many brand names (trade name)

Question 28

T or F, Generic names are not capitalized

Answer 28

True

Question 29

Describe the definition behind a Trade name for a drug

Answer 29

If the compound is found to be useful and will be marketed commercially, then the pharmaceutical company that discovered the drug gives the drug a trade name.

Question 30

T or F, After 17 years, the patent expires allowing other companies to market the generic drug under a trade name of their choosing

Answer 30

True

Question 31

How do you determine the margin of safety

Answer 31

LD50 divided by the ED50
LD=(lethal dose)
ED=(efficacious dose)

Question 32

If LD50=10 mg and ED50=2 mg, what is the margin of safety? What does this tell us?

Answer 32

10/2 = 5

This mens that the lethal dose is only 5 times the effective dose

Question 33

What is an acceptable margin of safety?

Answer 33

2000 or more

Question 34

What piece of legislation created the FDA? What were the requirements that the FDA would oversee

Answer 34

1906 - Pure Food and Drug Act

1. Drugs must meet standards of purity and quality
2. Manufacturers must provide correct and truthful labeling

Question 35

Which piece of legislation requires proof of a drug’s safety and purity

Answer 35

1938 Food, Drug and Cosmetic Act of 1938

-**This act was updated as the FDA Modernization Act of 1997

Question 36

Which piece of legislation grants the FDA authority to determine which drugs may be sold without a prescription?

Answer 36

Durham-Humphrey Act of 1952

Question 37

What piece of legislation requires proof of efficacy as well as safety for new drugs and drugs approved since 1938

Answer 37

1962 Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act

Question 38

Which piece of legislation says the FDA must demonstrate that a supplement is unsafe before taking action against it

Answer 38

Dietary Supplement Health and Education Act of 1994

Question 39

Discuss the authority that the FDA has over OTC drugs and dietary supplements

Answer 39

1. Dietary supplements cannot make therapeutic claims

2. Required to have the disclaimer: “this product is not intended to diagnose, treat, cure, or prevent any disease”