Test1

Question 1

Drug research standards in the US are set by

Answer 1

the FDA

Question 2

What are EXCIPIENTS

Answer 2

non-essential ingredients in drugs

Question 3

Why are EXCIPIENTS used

Answer 3

added to stabilize drugs, or to make them taste better, or to allay bacterial growth in medical applications

Question 4

The IND application is

Answer 4

the Investigational New Drug application

Question 5

What application does the FDA require prior to human testing during clinical trials

Answer 5

The IND application

Investigational New Drug

Question 6

What does the IND application need to include

Answer 6

Values from initial testing, including:

drug composition,
manufacturing, &
plan for testing on humans.

Question 7

Usually the IND application is approved by the FDA after ____ have passed.

Answer 7

30 days

Question 8

After the _____ application is approved by the FDA, the first of 3 phases of clinical trials can begin.

Answer 8

IND

Investigational New Drug

Question 9

____ is the emphasis of Phase I of clinical trials on human subjects.

Answer 9

Safety

Question 10

______ and ____ effects and side effects of a drug are ascertained in Phase I of clinical trials on human subjects.

Answer 10

pharmacological & physiological

also how long it takes to be metabolized and excreted

Question 11

____ is the emphasis of Phase II of clinical trials on human subjects.

Answer 11

Effectiveness (of the drug)

Question 12

Comparing the effects of placebo versus drug is tested in Phase __ of clinical trials on human subjects.

Answer 12

II

Question 13

The Drug Competition Action Plan was created by the ____ in 2017.

Answer 13

FDA

Question 14

In Phase ___ clinical trials, volunteers are recruited in the thousands.

Answer 14

III

Question 15

Drug interactions are determined in Phase __ clinical trials.

Answer 15

III

Question 16

___ ____ are determined in Phase III clinical trials.

Answer 16

Drug interactions

as well as further evaluation of safety and effectiveness

Question 17

________ studies requires finding healthy volunteers to demonstrate rate of absorption and excretion of compounds and excipients at the beginning of the clinical trials (and later for marketing).

Answer 17

Bioavailability

Question 18

What is the NDA in clinical trials?

Answer 18

New Drug Application

Question 19

After Phase ___ the NDA must be filed with the FDA.

Answer 19

IV

Question 20

The NDA request includes

Answer 20

All Phase I - III information

Animal and human data
Analysis of the data
How the drug behaves in the body
Manufacturing process

Question 21

Approximately half of drugs do not reach Phase ___

Answer 21

III

Question 22

Why do approx. half of drugs do not reach Phase III?

Answer 22

Safety and efficacy
or
fail to meet financial criteria set by investors

Question 23

A ____ formally asks for FDA approval to move a new drug to its commercial sale.

Answer 23

New Drug Application (NDA)

Question 24

_____ applications are required to be passed prior to human testing during clinical trials.

Answer 24

Investigational New Drug (IND)

Question 25

Phase __ studies can involve several hundred to several thousand subjects.

Answer 25

III

Question 26

Late-phase drug development, especially in Phase ___ clinical trials and later efforts, can account for the majority of the costs of the process as a whole.

Answer 26

III

Question 27

The IRB in clinical trials is composed of:

Answer 27

An independent board of
scientists, physicians, and nurses
who review the clinical trial protocol to ensure patient safety.

Question 28

IRB in clinical trials stands for:

Answer 28

Institutional Review Board