Drug Regulation, Development, Etc.

Question 0

What is the major reason for the Permission of accelerated drug approval?

Answer 0

To append up drug approval for important medications (cancer)

Question 1

What are the landmark drug legislation?

Answer 1

Federal pure food and drug act (1906)
Food, drug and cosmetic act (1938)
Harris-Kefauver amendments (1962)
Controlled substance act (1970) 
Permission of accelerated drug approval (1992)

Question 2

DEA developed 5 schedules regarding controlled substance. What are they?

Answer 2

I high potential for abuse/not accepted (heroin)
II high potential for abuse but a medical use
III moderate potential for abuse
IV low potential
V lowest potential

Question 3

Which two schedules does pain medication and morphine fall into?

Answer 3

Schedule II and schedule III

Question 4

Although schedule v is safest, can abuse still occur?

Answer 4

Yes, but much less

Question 5

In new drug development what type of trail must occur?

Answer 5

The randomized controlled trail.

Question 6

In randomized controlled trail what three types of trail occur?

Answer 6

Control
Randomization
Blinding

Question 7

What is control use?

Answer 7

Control/experimental group. Current treatment or placebo.

Question 8

What is randomization?

Answer 8

Patient can not make decision on taking drug or placebo. It is assigned.

Question 9

What is blinding?

Answer 9

No one knows who is in which group.

Question 10

What are the stages of new drug development?

Answer 10

Preclinical testing

Clinical testing

Question 11

How many phases are there in clinical testing?

Answer 11

IV phases

Question 12

What is phase IV used for in new drug development?

Answer 12

Postmarking surveillance

Question 13

What is used for testing in preclinical testing?

Answer 13

Animals

Question 14

What is used in clinical testing?

Answer 14

Humans

Question 15

How many species must be used for testing in preclinical?

Answer 15

Two

Question 16

In phase I how many healthy volunteers must be in the study and what is being tested?

Answer 16

50, safety and dosage

Question 17

In phase II how many patients must be in the study and what is being tested?

Answer 17

200-500, evaluate effectiveness

Question 18

In phase III how many patients must be in the study and what is being tested?

Answer 18

2,000-5,000, confirm effectiveness common side effects.

Question 19

In phase IV what is being tested?

Answer 19

Common and rare side-effects

Question 20

In phase IV, post-market surveillance, what should be occurring?

Answer 20

Doctors are supposed to report side effects.

Large scale trials should continue

Question 21

What are the limitations of testing procedure?

Answer 21

Limited info on women and children

Failure to detect all adverse side effects.

Question 22

What should be added to a hand written prescription and why?

Answer 22

Generic name so patient can read there own prescription.

Question 23

What are the three types of drug names?

Answer 23

Chemical
Generic
Trade

Question 24

What is the chemical name of a drug used for?

Answer 24

Only uses by scientist and other researchers.

Question 25

A generic name is granted by what council?

Answer 25

United States adopted names council