Intro

Question 1

Pharm is the study of

Answer 1

Substances that alter bodily functions when introduced into the organism

Question 2

History of pharm

17th century
18th-20th century
60 yrs ago
Future

Answer 2

17th: Observation and experimentation began to replace theory. Science of drug prep began.
18-20th: Advances in chemistry allowed for understanding of how drugs work.
60 yrs ago: Controlled clinical trials began.
Future: Study genetic makeup and individual response to specific drugs.

Question 3

True or false. Every drug you recommend will have side effects

Answer 3

TRUE. BUT not every patient will experience every side effect. There is always a little bad to go with the good.

Question 4

Drug

Answer 4

Any substance that alters body function when introduced into a living organism. Has some effect on a specific target molecule (receptor).

Question 5

Pharmacodynamics

Answer 5

The actions of a drug on the body. What does the drug do at the receptor?

Question 6

Pharmacokinetics

Answer 6

The actions of the body on a drug. How the drug moves from site of administration to target and then out of the body. Absorption, metabolism, and excretion

Question 7

Two types of agonists

Answer 7

Bind to and activates a receptor.
Full: Light switch on or off.
Partial: Dimmer light switch

Question 8

Two types of antagonists

Answer 8

Prevents other molecules from binding to a receptor- so it cannot be activated.
Reversible or irreversible

Question 9

Administration

Answer 9

How you give a drug

Question 10

Absorption

Answer 10

1 body compartment to another.

Question 11

Pro drug

Answer 11

A drug may reach its intended target as an active molecule or it might require conversion prior to being active. Usually metabolism.

Question 12

3 steps to pharmacokinetics

Answer 12

Absorption–> Distribution –> Elimination

Question 13

How can a drug be eliminated after it has an effect?

Answer 13

Metabolism

Kidney (most common)

Question 14

5 Drug classifications

Answer 14

natural 
Pure
Semi-synthetic 
Synthetic 
Biological

Question 15

6 Drug classifications in terms of therapeutic effect

Answer 15

Anti:
Hypertensives 
Convulsants 
bacterial
Fungal
Psychotic
Arrhythmics

Question 16

Drugs have 3 names

Answer 16

1. Chemical name.
2. Generic name (All drugs only have 1!)
3. Brand name. Patented. One drug may have many trade names.

Question 17

1. Patent on a drug lasts how many years
2. Trade name lasts for at least
3. Time from patenting to marketing takes

Answer 17

1. 20. Exclusive rights to sell can be much shorter due to conditions and competition. Often includes the approval time which can be 5 years or more. Average is 11 yrs.
2. 50 yrs.
3. 8-10 years.

Question 18

Efficacy

Answer 18

How well it works

Question 19

Potency

Answer 19

Strength

Question 20

Selectivity

Answer 20

Side effects

Question 21

New drugs are developed through these approaches:

Answer 21

1. Identification of new drug target.
2. Design of new molecule based on understanding of receptor structure
3. Screening for biological activity of natural products
4. Chemical modification of known molecule. Copy cat

Question 22

Drug screening

Answer 22

Depends on pharmacologic and therapeutic goal. Tested for other actions, pharmacokinetics, pharmacodynamics, animal studies to determine effect on organ system. All done before human studies.

Modifications may be made as a result Consider interactions with liver enzymes, potential for abuse, other drug interactions.

Question 23

lead compound

Answer 23

The result of all drug screening procedures.

New command= patent application
Previously known chemical= Use patent

Question 24

Lead compound moves to Preclinical testing after drug screening. Preclinical testing involves

Answer 24

Toxicity testing.
1. Acute toxicity (lowest dose with no effect and max tolerated dose)
2 Subacute toxicity (Long term- week to month- side effects?)
3. Chronic (Prolonged use)
4. Effect on reproductive organs
5. Carcinogenic
6. Mutagenic

Question 25

Limitations to preclinical testing

Answer 25

Time consuming.
Large numbers of animals needed
Animal to human toxicity data is not always predictive
Rare adverse effects are likely not to be identified

Question 26

Human testing is overseen by

Answer 26

The FDA

Question 27

Clinical trials filed with the FDA is called

Answer 27

Notice of claimed investigational exemption for a new drug (IND). Includes ALLLL info.

Question 28

Clinical trials phase 1

Answer 28

Healthy volunteers.
Small number (20-100)
Goal is to determine the safe dose limits. 

Absorption, half life and metabolism studied.
Can use on sick individuals IF the drug has significant toxicity.

Question 29

Clinical trials phase 2

Answer 29

Sick individuals
Small number of patients (100-200)
Determine efficacy- does it even work? WHERE MOST DRUGS FAIL. only 25% get past this.

Question 30

Clinical trials phase 3

Answer 30

Sick individuals
More patients- thousands
Confirming safety and efficacy
Performed in settings similar to where it’s intended to be used. Ex: Hospitals, clinics.

If drug meets expectations, application is made for permission to market drug

Question 31

What happens after phase 3 of clinical trials?

Answer 31

Marketing approval. Must submit a new drug application (NDA) with full reports of all preclinical and clinical data Can take months to years to gain approval from FDA.

Question 32

Once the drug is approved, phase 4 studies begin. What is this?

Answer 32

Physicians using the drug report unknown or surprise side effects. This phase lasts as long as the drug is out.

Monitor safety of it in large number of patients.

Question 33

What happens when the patent expires?

Answer 33

Any company can produce the drug without paying license fees to the original patent owner. Generic. Can file for an abbreviated new drug application (ANDA)

Question 34

___% of prescriptions in the US are for generics

Answer 34

67%