Drug Regulation

Question 1

At what step is equivalency determined for generic vs non generic drugs?

Answer 1

Absorption.

Question 2

Federal Govt determines

Answer 2

Which drugs can be proscribed.

Question 3

Stat Govt determines

Answer 3

Who can proscribe drugs

Question 4

What is the highest, most potent “schedule” of drug?

Answer 4

Schedule I.

Not for medical use

Question 5

True/False: Schedule 2 drugs can be phoned in and refilled

Answer 5

False

Question 6

What is the purpose for animal studies of a drug?

Answer 6

1)attempt to find appropriate dosage and 2) use

Question 7

What is the purpose for phase I studies of a drug?

Answer 7

Is it safe?

Administer to healthy individuals
Evaluate SAFETY

Question 8

What is the purpose for phase II studies of a drug?

Answer 8

Does it work?

Evaluate SAFTEY and EFFICACY

Question 9

What is the purpose for phase III studies of a drug?

Answer 9

Does it work double blind?

EFFICACY AND SAFETY measured.
Adverse reactions measured for long term use.

Question 10

What categories are scheduled drugs classified into?

Answer 10

Medical Use
Abuse potential
Psych Dependance
Phsyio Dependance