Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Law > New Drugs To Market > Flashcards

New Drugs To Market Flashcards

You may prefer our related Brainscape-certified flashcards:
Civil Procedure 1L flashcards MBE flashcards MPRE flashcards
1
Q

How long does the FDA have to decide on an IND?

A

30 days

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

How many phases of testing must occur before final approval?

A

3 phases

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

How many phases are there after the drug product has been marketed?

A

1 (phase 4)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What phase testing is in healthy individuals?

A

Phase 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What phase establishes safety in humans?

A

Phase 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What phase determines effectiveness?

A

Phase 2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What phase helps establish info about adequate dosing?

A

Phase 2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What phase of testing is large groups of people in several geographical locations?

A

Phase 3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What allows administration of a new drug to patients not enrolled in the new drugs clinical trial?

A

Treatment IND

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What is a requirement of treatment IND?

A

Imminent life threatening illness with presently no cure

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What phases just a drug be in for a treatment IND?

A

Phase 2 and 3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What point can the manufacturer market the new drug?

A

After approval of phase 1-3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What application is required for new generics?

A

Abbreviated NDA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What application allows manufacturers to make changes to a drug?

A

Supplemental NDA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Any changes made by the company that filed the original NDA will probably require what application?

A

Supplemental IND

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

If another company other than the original NDA holders file, it’s most likely what application?

A

Abbreviated NDA

17
Q

What type of therapeutic classification shows a major therapeutic gain?

A

Type P

18
Q

What type of therapeutic classification indicates that the drug is similar to other drugs in the market?

A

Type S

19
Q

Who’s responsibility is it to designate generic names for new drugs?

A

U.S. Adopted Names Council

20
Q

What must be filled out before administering a new drug to humans?

A

IND

21
Q

What therapeutic equivalency code means they are considered therapeutically equivalent to other drugs?

A

A

22
Q

What therapeutic equivalent code means these drugs have actual or potential bio equivalence problems that have it been resolved?

A

B

23
Q

If two drugs contain sale active ingredient, are they therapeutically equivalent?

A

No

24
Q

If pharmaceuticals equivalent, are they therapeutically equivalent?

A

No always

25
Q

If a drug has the same therapeutic moiety but with different salts esters or complexes or have different dosage forms or strengths, what are they considered?

A

Pharmaceutical alternatives

26
Q

If drug products display compare able bioavailability when studied under similar experimental conditions, what are they considered?

A

Bio equivalents

Law (11 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions