Quiz 3

Question 1

Produces a defined toxic effect in 50% of the individuals tested

MEC
MTC
Median Effective Dose
Median Toxic Dose

Answer 1

Median Toxic Dose

Question 2

Produces the desired intensity of effect in 50% of the individuals tested

Median Effective Dose
MEC
Median Toxic Dose
MTC

Answer 2

Median Effective Dose

Question 3

Area from ICH which includes - stability, light stability, analytical
validation, impurities & biotechnology

Safety topic
Quality topic
Regulatory topic
Efficacy topic

Answer 3

Quality Topic

Question 4

Regularly schedule subsequent administration to keep the most desirable
concentration of drug in the blood

Loading dose
Therapeutic dose
Prophylactic dose
Maintenance dose

Answer 4

Maintenance dose

Question 5

Factors in determining drug’s dose, EXCEPT:

Age
Concomitant drug therapy
Pathologic condition
Body weight
Room temperature

Answer 5

Room Temperature

Question 6

Manufacturing scale-up activities

Answer 6

Phase IV

Question 7

Determine drug tolerance and toxicity

Answer 7

Phase I

Question 8

Subjects: Healthy volunteers (20100)

Answer 8

Phase I

Question 9

Submission of NDA

Answer 9

Phase III

Question 10

Subjects: Patients with disease (several hundreds-several thousands)

Answer 10

Phase III

Question 11

Submission of IND

Answer 11

Preclinical Stage

Question 12

Post Marketing Surveillance

Answer 12

Phase V

Question 13

Animal Pharmacology and Toxicology data are obtained

Answer 13

Preclinical stage

Question 14

Determines the therapeutic index

Answer 14

Phase II

Question 15

Side effects are monitored

Answer 15

Phase III

Question 16

Determines minimum concentration expected to produce the drug’s
desired effects in a patient
MEC
MTC
Median Effective Dose
Median Toxic Dose

Answer 16

MEC

Question 17

Therapeutic index is the ratio of drug’s median effective dose & median
toxic dose (EF50/TD50)
True
False

Answer 17

FALSE

Question 18

Dose that protects the patient from contracting the illness
Loading dose
Prophylactic dose
Therapeutic dose
Maintenance dose

Answer 18

Prophylactic Dose

Question 19

FDA terminate an IND application for any safety, efficiency or regulatory
compliance issues
True
False

Answer 19

True

Question 20

A drug product label provides information on the packaging, in package
insert, and in company literature, advertising, and promotion materials
True
False

Answer 20

True

Question 21

Dose administered to the patient after exposure or contraction of the
illness.
Maintenance dose
Loading Dose
Prophylactic Dose
Therapeutic dose

Answer 21

Therapeutic Dose

Question 22

Which is NOT a part of a clinical protocol?
Purpose and objectives
Subject selection
Investigational plan
Dosing plan
None of the choices

Answer 22

None of the choices

Question 23

Which is NOT a component of a drug product label?

Adverse reactions
Warnings
Indications and usage
Suggested retail price
Dosage and administration

Answer 23

Suggested Retail Price

Question 24

The purpose of NDA is to gain permission to market the drug product

True
False

Answer 24

True

Question 25

Dosage regimen is determined from: Clinical investigation Pharmacokinetics Characteristics of dosage form Inherent duration of action All of the choices

Answer 25

All of the choices

Question 26

How many days will FDA evaluate/ review a New Drug Application? within 200 days within 80 days within 280 days within 180 days

Answer 26

Within 180 days

Question 27

Identify the compounds

Answer 27

Discovery stage

Question 28

Submission of NDA

Answer 28

Development stage

Question 29

Human clinical trial phase II

Answer 29

Development stage

Question 30

Select clinical candidates

Answer 30

Discovery stage