Pharm Week 3

Question 1

Pharmacology

Answer 1

the study of the interactions of chemicals, other than food, w/ living systems.
It is a science based upon an understanding of organic chemistry, biochemistry, physiology, pathology and microbiology that focuses on the mechanism of action of drugs on living systems.

Question 2

Pharmacodynamics

Answer 2

mechanism of drug action

Question 3

pharmacokinetics

Answer 3

absorption, distribution, metabolism and elimination of drugs

Question 4

Therapeutics

Answer 4

the application of pharmacology to the problems of clinical medicine

Question 5

chemotherapy

Answer 5

the use of drugs, which ideally have little effect of the host (patient) but destroy or retard the growth of invading cells and organisms

Question 6

Safety pharmacology

Answer 6

discipline focused on the mechanism of action (MOA) of unwanted effects of drugs in humans during drug product development

Question 7

Toxicology

Answer 7

focuses on harmful effects of poisons, environmental and industrial chemicals and drugs on the human body

Harmful effects often focused on from the POV of dose

Question 8

Pharmacy

Answer 8

the science broadly interested in all aspects of drugs, w/ 2 primary emphases: one on manufacture, compounding, preparation and dispensing of drugs; the other on the therapeutic management of drug treatment of patients (therapeutacist)

Question 9

Generic name

Answer 9

the assigned name of a drug, by which it will be known throughout the world no matter how many different companies manufacture it

Ex. beta-adrenergic receptor blocker for HTN

Question 10

Official name

Answer 10

the name by which a drug is listed in official publications

The official name is often the same as the generic name

Question 11

Trade name

Answer 11

the name that is given by a particular company that is manufacturing the drug

Ex. Ibuprofen is sold under these names: Motrin, Advil, Nurofen

Question 12

Clinical Trials Phase I

Answer 12

Need 20-100 HEALTHY volunteers

Objective:
how to best administer
verify safety and tolerability
evaluate how the drug acts in the body: absorbed, distributed, metabolized, excreted

9-18 months

Question 13

Clinical Trials Phase II

Answer 13

Need 30-40 control and test subjects (healthy AND diseased volunteers)

Objective:
test patient response to treatment
if 1/5 respond, considered successful
establish dosage range
long term, chronic toxicity studies initiated

18-24 months

Question 14

Clinical Trials Phase III

Answer 14

Need 100-1000+ volunteer patients suffering from the condition

Objective:
Determine whether the drug is of clinical benefit in the condition
Expanded testing of effectiveness and safety in randomized and blinded studies

2-4 years

After phase III, the drug is believed to be safe and effective

Question 15

Testing Humans Follow-up Phase IIIb/IV

Answer 15

Need volunteer patients (number varies)

Objective:
III - provides additional safety data or tests on additional conditions

IV - expansion of testing to broader patient populations
Complete any phase III trials
compares long-term effectiveness and/or cost with other drug alternatives

Ongoing, but with close scrutiny for 1-2 yrs

Question 16

Post- market studies

Answer 16

New age group or patient types

Objective:
Continued assurance of safety and efficacy
Some focus on previously unknown side effects

Ongoing; several months or several years

Question 17

Good laboratory practices (GLP)

Answer 17

regulatory guidelines followed by a validated laboratory to ensure each and every step of the study/experiment is validated

The purpose is so that every step performed in a study/experiment can be precisely and accurately repeated