clinical drug trial

Question 0

Which phase most commonly used healthy subjects?

Answer 0

Phase 1

Question 1

Out of phases 1-4 which phase of drug trials are double-blind?

Answer 1

Phase 3

Question 2

Which phase determines response and dosing regiment?

Answer 2

Phase 2

Question 3

Which phase focuses on long term risks and benefits?

Answer 3

Phase 4

Question 4

Which phase provides adequate basis for extrapolating results to the general population?

Answer 4

3

Question 5

Which phase is intended to establish safety and tolerability?

Answer 5

Phase 1

Question 6

Which phase determines that effectiveness of a drug for a certain disease?

Answer 6

Phase 2

Question 7

How can you prevent subject/participant bias?

Answer 7

Placebo use

Question 8

How can you prevent observer bias?

Answer 8

Blinding

Question 9

How can you prevent selection bias?

Answer 9

Randomizing

Question 10

When the sponsor submits preclinical research data to the FDA to proceed with human clinical trials this is what?

Answer 10

Investigational new drug application

Question 11

What board ensures the rights and welfare of clinical trial participants before and during the trial?

Answer 11

The institutional review board (IRB)

Question 12

When a sponsor formally proposes that the FDA approve a new drug for sale in the US

Answer 12

New drug application

Question 13

Reviews safety and efficacy data on an interim basis?

Answer 13

The data and safety monitoring board

Question 14

Accelerated development and approval for serious life-threatening disease

Answer 14

Fast track status

Question 15

For a disease the effects <200,000 pts in the US, 7 yrs exclusivity patent

Answer 15

Orphan drug

Question 16

Meds in phase 3 development–gives access to patients who may not survive

Answer 16

Compassionate use

Question 17

True or false. Generic drugs have to undergo an approval process identical to that of the innovator drug

Answer 17

False

Question 18

Generic drugs must meet the same batch requirements for identity, strength, purity, and quality as the innovator drug

Answer 18

True

Question 19

Generic drugs are more expensive and more effective than their innovator counterparts

Answer 19

False

Question 20

Generic drugs must have the same what ingredients as the innovator drug?

Answer 20

Active

Question 21

A generic drug must be bio equivalent to the innovator drug. This means it must have the same what 4 things?

Answer 21

Absorption, distribution, metabolism, and excretion

Question 22

What is the goal of med watch? Who can report adverse events to the spontaneous adverse events reporting system?

Answer 22

To capture serious adverse events, anyone