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DDS LEC > Quiz 3 > Flashcards

Quiz 3 Flashcards

1
Q

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

MEC
MTC
Median Effective Dose
Median Toxic Dose

A

Median Toxic Dose

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2
Q

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

Median Effective Dose
MEC
Median Toxic Dose
MTC

A

Median Effective Dose

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3
Q

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

Safety topic
Quality topic
Regulatory topic
Efficacy topic

A

Quality Topic

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4
Q

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

Loading dose
Therapeutic dose
Prophylactic dose
Maintenance dose

A

Maintenance dose

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5
Q

Factors in determining drug’s dose, EXCEPT:

Age
Concomitant drug therapy
Pathologic condition
Body weight
Room temperature

A

Room Temperature

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6
Q

Manufacturing scale-up activities

A

Phase IV

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7
Q

Determine drug tolerance and toxicity

A

Phase I

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8
Q

Subjects: Healthy volunteers (20100)

A

Phase I

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9
Q

Submission of NDA

A

Phase III

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10
Q

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

A

Phase III

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11
Q

Submission of IND

A

Preclinical Stage

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12
Q

Post Marketing Surveillance

A

Phase V

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13
Q

Animal Pharmacology and Toxicology data are obtained

A

Preclinical stage

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14
Q

Determines the therapeutic index

A

Phase II

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15
Q

Side effects are monitored

A

Phase III

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16
Q

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

A

MEC

17
Q

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

A

FALSE

18
Q

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

A

Prophylactic Dose

19
Q

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

A

True

20
Q

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

A

True

21
Q

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

A

Therapeutic Dose

22
Q

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

A

None of the choices

23
Q

Which is NOT a component of a drug product label?

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

A

Suggested Retail Price

24
Q

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

True
False

A

True

25
Q

Dosage regimen is determined from:

Clinical investigation
Pharmacokinetics
Characteristics of dosage form
Inherent duration of action
All of the choices

A

All of the choices

26
Q

How many days will FDA evaluate/ review a New Drug Application?

within 200 days
within 80 days
within 280 days
within 180 days

A

Within 180 days

27
Q

Identify the compounds

A

Discovery stage

28
Q

Submission of NDA

A

Development stage

29
Q

Human clinical trial phase II

A

Development stage

30
Q

Select clinical candidates

A

Discovery stage

DDS LEC (7 decks)

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