Chapter 1

Question 1

Critical path initiative

Answer 1

A national strategy “to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured.”

Question 2

Core ethical principles

Answer 2

Respect for persons, beneficence, justice

Question 3

Respect for persons

Answer 3

Patients should be treated as independent persons who are capable of making decisions in their own best interest. Ex.) being aware of alternatives and autonomy

Question 4

Informed consent

Answer 4

Respect for persons
Voluntary and the right to be informed. Should be written at or below an 8th grade level and have fewer than three syllables in a word

Question 5

Clinical drug trial

Answer 5

Drug discovery: test drug compounds in animals and tissues
Phase1: test drug for safety
Phase 2: test effectiveness
Phase 3: confirm safety and effectiveness in 1,000+
Submit to FDA
Phase 4: test for long-term effects, optimal and additional uses

Question 6

Beneficence

Answer 6

Duty to protect research subjects from harm

Question 7

Justice

Answer 7

Selection of research subjects is fair

Question 8

Consent form for clinical trial

Answer 8

Title of study
Principle investigator 
Institute
Intro
Background info
Purpose
Procedures
Possible risks or benefits 
Right of refusal 
Confidentiality 
Available sources for information

Question 9

Provisions

Answer 9

1: practice with compassion and respect
2: commitment to the patient
3: promotes and advocates
4: authority, accountability, and responsibility
5: owes the same duty as self to others
6: improves ethical environment
7: advances the profession
8: collaboration
9: integrate principles

Question 10

Scheduled category 1

Answer 10

Heroin, lysergic acid diethylmide, cannnibis

No current accepted medical use in the US

Question 11

Scheduled category 2

Answer 11

Hydromorphone, methadone, meriperidine, ocycodone, Fentonyl, cosine, hydrocodone, morphine, opium, cocaine

HIGH POTENTIAL FOR ABUSE

Question 12

Schedule 3

Answer 12

15mg of hydrocodone or 90mg of code3ine

Benzphetamine, phendimatrazine, ketamine, steroids

Question 13

Schedule 4

Answer 13

Alprzolum, carisoprodal, clonazepam, Valium, Xanax

Question 14

Schedule 5

Answer 14

Cough preparations contains less than 200mg per 100 ml of codeine, intidiureals

Question 15

Chemical name

Answer 15

Describes chemical structure

Question 16

Generic name

Answer 16

Lower case and universally accepted

Question 17

Brand name

Answer 17

Capitalized

Propriety name

Question 18

OTC drugs must hav

Answer 18

Ingredients and amount in each dose
Purpose of product
The uses
Specific warning and side effects
The products in active ingredients