Brainscape's Knowledge GenomeTM

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


See full index

Pharmacology > Drug development and safety > Flashcards

Drug development and safety Flashcards

1
Q

First 4 steps in the process of drug development

A
  1. Isolate or synthesize a new drug
  2. Determine chemical/pharmaceutical properties of the drug
  3. Determine the kinetics/dynamics
  4. Test animals for toxicity (acute, subacute, chronic) and teratogenesis, mutagenesis, and carcinogenesis
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Second 3 steps in the process of drug development

A
  1. Outline properties of the drug
  2. Report results of studies
  3. Propose clinical studies
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What does IND stand for

A

Investigational new drug

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

What are the steps during the IND application phase of drug development

A
  1. outlining properties,

2. report results of case studies, 3. propose clinical studies

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

What are the steps in the discovery and characterization phase

A
  1. Isolate/synthesize new drug

2. Determine chemical/pharm properties of drug

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

What are the steps during the experimental studies phase of drug development

A
  1. Determine kinetics/dynamics of a drug

2. Test animals for toxicity and mutations

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

What are the steps during the clinical studies phase

A

Phase 1
Phase 2
Phase 3

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

What happens during phase 1

A

Gathering data on drug safety and kinetics in HEALTHY VOLUNTEERS

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

What happens during phase 2

A

Gathering data on efficacy, safety, proper dosage in a SMALL group of pts

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

What happens during phase 3

A

Obtain statistical evidence of drug safety and efficacy. LARGE group of patients

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

What are the steps during submission of NDA

A
  1. Outline the properties of the drug
  2. Report results of all experiments and clinical trials
  3. Propose labeling of drug and clinical indications (for use)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What does NDA stand for

A

New drug approval

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

What are the final steps (2) in the drug development process

A
  1. NDA approval

2. Postmarketing surveillance

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

What is the difference between IND and NDA

A

IND is investigational new drug and it is the early stages of drug (before clinical trials). Where as NDA is the actual approval of the new drug for market

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

What happens after experimental studies

A

IND application

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

What happens after IND application

A

Clinical studies (phase 1,2,3)

17
Q

What happens after clinical studies

A

Submission of NDA application

18
Q

What is the Federal Food, drug and cosmetic act (FFDCA)

A

It is a law that was passed in 1938 that allows the FDA to oversee the safety of food, drug, and cosmetics

19
Q

How has the FFDCA effect drug safety

A

Drug companies must show that the product is safe before marketing

20
Q

What was added to the FFDCA in 1968

A

Drug efficacy study implementation was added.

Drugs had to be studied with controlled trials

21
Q

What are 2 federal laws/regulations designed to prevent drug abuse

A
  1. Harrison Narcotic act of 1914

2. Comprehensive Drug Abuse Prevention and Control Act

22
Q

What was the purpose of the Harrison narcotic act of 1914

A

Regulate the production, importation, and distribution of opiates and coca products

23
Q

What does the comprehensive drug abuse prevention and control act do (aka federal controlled substance act)

A

Classification of drugs into their 5 schedules

24
Q

Class 1 drugs

A

HIGH potential for abuse, no legitimate medical use (cocaine, ecstasy)

25
Q

Class 2 drugs

A

High abuse potential but a legitimate medical use-must be highly controlled. (Morphine, methadone)

26
Q

Class 3,4,5 drugs

A

Have lower abuse potential and fewer restrictions on distributions

27
Q

Examples of class 3 drugs

A

Steroids

28
Q

Examples of class 4 drugs

A

Valium, xanax

29
Q

Examples of class 5 drugs

A

Cough syrups, codeine

30
Q

What is FAERS

A

FDA adverse event reporting system. The database contains information on adverse events and medication errors reported to the FDA

31
Q

Who reports to FAERS

A

Anyone and it is voluntary

32
Q

How do you report and adverse event or medication error

A

The MedWatch site

Pharmacology (9 decks)

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