Chapter 1/2 Information

Question 1

Who is responsible for the drug approval process?

Answer 1

FDA

Question 2

How many phases are there of the testing process and what are they?

Answer 2

0-drug testing occurs in animals/ small groups had m of humans. FDA’ drug ‘ evaluation and research (CDER) review results
1- few doses given to healthy subjects, determine safe dosage, administration, absorption, metabolism, excretion and toxicity
2- free doses given to subjects with disease/ symptoms that drug targets, then compared to healthy subjects
3- drug given to different populations, dosages, and used with other drugs
-double blind study performed
-tests if benefits outweigh the risks
- testing stops if inadequate effectiveness or excessive toxicity
4. FDA allows drug to be marketed but drug is continually monitored

Question 3

What is a black box warning?

Answer 3

Drugs that cause serious adverse effects

Question 4

What is a controlled substance?

Answer 4

Drugs categorized according to therapeutic usefulness and potential for abuse

Question 5

How many schedules of controlled substances are there and describe them?

Answer 5

There are 5 categories
1. No accepted medical use, high abuse potential