PM- FUNDAMENTAL CONCEPTS

Question 1

The study of drugs and their interactions with living systems.

The study of biological effects of chemicals.
It encompasses the study of physical and chemical properties of drugs as well as their biochemical and physiologic effects.

Also includes knowledge of history, sources, and uses of drugs as well as knowledge of drug absorption, distribution, metabolism, and excretion.

Answer 1

Pharmacology

Question 2

any chemical that can affect living processes.

Answer 2

Drug

Question 3

also called as,_______ branch of pharmacology that uses drugs to treat, prevent, and diagnose disease. This addresses 2 key concerns - the drug’s effect on the body and the body’s response to the drug

Answer 3

Clinical pharmacology - pharmacotherapeutics

Question 4

what are the two sources of drugs

Answer 4

1. natural sources (plants ex lagundi marijuana, animal products(insulin sources), inorganic compounds-aluminum for hyperacidity,)
2. synthetic drugs- commercially prepared medications

Question 5

chemicals that may have therapeutic value are tested on laboratory animals for 2 main purposes:

Answer 5

Preclinical trials

Question 6

chemicals that stay within reasonable safety margins and therapeutic at doses proceed to______

Answer 6

from preclinical phase TO phase 1

Question 7

for preclinical trials what do they use to test the chemical

Answer 7

animals (rats)

Question 8

in this phase they use human volunteers to test the drugs. More tightly controlled than preclinical trials and one performed by specially trained clinical investigators

Answer 8

Phase 1 Studies

Question 9

what type of subjects do they prefer in a Phase 1 studies

Answer 9

healthy young men

Question 10

T OR F: in phase 1 studies, despite the undesirable effects some chemicals move to the next stage of testing

Answer 10

TRUE

Question 11

allows clinical investigators to try out the drug in patients who have the disease that the drug is designed for.

Answer 11

Phase II Studies -

Question 12

T OR F: PHASE 2 Usually performed at various sites - in hospitals, clinics, doctors’ offices - and are monitored by representatives of the pharmaceutical company studying the drug.

Answer 12

T

Question 13

• involve use of the drug in a vast clinical market. nformation will be collected by the drug company and shared with FDA (Food and Drug Administration).

Answer 13

Phase III Studies

Question 14

committees of experts familiar with the specialty area in which the drugs will be used.

Answer 14

Food and Drug Administration Approval

Question 15

How long can drug development and approval process take?

Answer 15

5-6 years

Question 16

how is an approved drug named?

Answer 16

An approved drug is given the brand name by the pharmaceutical company that developed it

Question 17

phase IV studies is also known as?

Answer 17

Postmarketing Surveillance, continual evaluation.

Question 18

Prescribers are obligated to report to FDA any untoward or unexpected adverse effects associated with the drugs.

Some drugs cause unexpected effects that are not seen until wide distribution occurs.

Answer 18

Phase IV Studies

Question 19

original designation that the drug was given when the drug company applied for the approval process.

Answer 19

Generic Name - also Nonproprietary Name,

Question 20

given by the pharmaceutical company that developed the drug.

Answer 20

Brand Name - also Trade or Proprietary Name

Question 21

reflect the chemical structure of a drug

Answer 21

Chemical Names