Drug Development

Question 1

Pharmaco -kinetics

Answer 1

Fate of a drug -> dosing, drug interactions. (What the body does to a drug)

Question 2

Pharmaco - dynamics

Answer 2

Action of a drug -> mechanism of action
(What a drug does to the body)

Question 3

Pharmaco- therapeutics

Answer 3

Clinical use of drugs

Question 4

Pharmaco-genetics

Answer 4

How genetics alter drug responses

Question 5

Pharmaco -epidemiology

Answer 5

Effects of drugs on populations

Question 6

Pharmaco -economics

Answer 6

Cost effectiveness of drug treatment

Question 7

Toxicology

Answer 7

Study of the harmful effects of drugs and other substances

Question 8

Example of Pharmaco -genetics

Answer 8

Pythagoras and fava beans are metabolized by G6PD

Question 9

Contradictions

Answer 9

Situations or circumstances when a particular drug should not be used. (Aspirin in patients with bleeding disorders)

Question 10

Natural drugs

Answer 10

Drugs made from natural resources such as (plants, venoms…)

Question 11

Synthetic drugs

Answer 11

Chemically synthesized drugs. Often modeled after natural drugs (fentanyl is a synthetic morphine )

Question 12

Biologics

Answer 12

Newest class of drugs. Vaccines, antibodies , growth factors , gene therapy

Question 13

Compound

Answer 13

A chemical used for pharmacological purposes. (Prototype drug)

Question 14

Pharmacologic tool

Answer 14

A pharmacologically active chemical used for experimental purposes

Question 15

Selectivity

Answer 15

A selective drug affects only one target over the therapeutic range

Question 16

Selective toxicity

Answer 16

Aim to kill the microorganism/ parasite/ unwanted cell (cancer) but leaves the host cells unharmed

Question 17

ED50

Answer 17

Effective dose 50. ( median effective dose) 50% of patients experience a therapeutic effect

Question 18

TD50

Answer 18

Toxic dose 50 (median toxic dose). 50% of patients experience toxic effects

Question 19

Therapeutic window

Answer 19

The dosage range which can treat a disease effectively while staying within the safety range

Question 20

Earliest records on the use of drugs

Answer 20

Egyptian medical papyrus 1600BC

China and India 2000BC

Question 21

Samuel Hahnemann (1755–1843)

Answer 21

German physician and founder of Homeopathy

First systematic and experimental approach to pharmacology

Question 22

Chemical name

Generic name

Brand name

Answer 22

Chemical name : C8H9NO2

Generic name : acetaminophen

Brand name : Tylenol

Question 23

Orphan drugs

Answer 23

Durga used for rare disorders (often not profitable for the pharmaceutical industry ). Status given by FDA

Question 24

Patent protection

Answer 24

Once a company discovers a new drug they typically file a patent that gives them exclusive right for 20 years

Usually only have 10 years left on patent by the time drug is approved

Question 25

Bio equivalence

Answer 25

Drugs can be chemically exact not not bio equivalent ( may not effect the body in exactly the same way)

Question 26

Clinical phase 1

Answer 26

Testing in healthy patients

Safety , tolerability , pharma kinetics

Question 27

Clinical phase 2

Answer 27

In patients with disease

Optimize drug dosage and confirm efficacy

Single or double blind

Question 28

Clinical phase 3

Answer 28

Tested on hundreds to thousands of patients

Gather info on effectiveness and safety

Double blind

Question 29

Clinical phase 4

Answer 29

Evaluate in real world settings

Identify rare or long term side effects and monitor overall performance

Question 30

Clinical phase 4

Answer 30

Evaluate in real world settings

Identify rare or long term side effects and monitor overall performance