Chapter 1 - Drug Development and Ethical Considerations

Question 1

the right to self-determination

Answer 1

autonomy

Question 2

the duty to do good and to not harm others

Answer 2

beneficence

Question 3

principle that all people be treated fairly, including equal access to health care for all

Answer 3

justice

Question 4

subjects in thisgroup receive the treatment or drug under the study. They are randomly assigned and not selected. They should have similar baseline characteristics to those in the control group. They do not receive a placebo

Answer 4

experimental group

Question 5

performed in animals or other living organisms

Answer 5

preclinical in vivo testing

Question 6

which phase of clinical experimentation do researchers test a new drug or treatment in a mall group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects

Answer 6

Phase 1

Question 7

which phase of clinical experimentation is the drug or treatment given to al larger group of people to see if it is effective and to further evaluate its safety.

Answer 7

Phase 2

Question 8

which phase of clinical experimentation is the drug or treatment given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the durum or treatment to be used safely

Answer 8

Phase 3

Question 9

which phase of clinical experimentation stored are done after the drug or treatment has been marketed to gather information on the drug’s effects in various populations and to assess any side effects associated with long term use

Answer 9

Phase 4

Question 10

which group in a study may receive not drug, a different drug, a placebo, or the same drug with a different dose, route or frequency of administration

Answer 10

control group

Question 11

requires health care professionals to tell the truth

Answer 11

veracity

Question 12

which act requires the drugs intended for use in children to be tested on children

Answer 12

US Food and Drug Administration Modernization Act of 1997

Question 13

what designation is given to drugs that have met high standards for therapeutic use, patient safety, quality, purity, strength, packaging safety, and dosage form.

Answer 13

“United States Pharmacopeia (USP)”

Question 14

who classifies controlled substance with Roman numerals from I-V

Answer 14

FDA

Question 15

what requires drug manufacturers to test drugs in children

Answer 15

Pediatric Research Equity Act

Question 16

What are the responsibilities of the FDA

Answer 16

Ensures that drugs are labeled correctly, tested and proven effective for the conditions that they are marketed to treat, they re tested for harmful effects