Brainscape's Knowledge GenomeTM

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


See full index

Pharmacology > Drug development and regulation > Flashcards

Drug development and regulation Flashcards

1
Q

Pure food and drug act (PFDA)

A

Prohibits mislabeling and adultering drugs

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

Amendment to PFDA

A

Prohibits false/fraudulent advertising claims

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

Harrison narcotics act**

A

Established regulations for use of opium, opiates, cocaine and later marijuana

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

Controlled substances act of 1970***

A

Outlines strict controls in the manufacture, distribution and prescribing of habit-forming drugs;
Establish program to prevent and treat addiction***

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

Drug Price Competition and Patent Restoration act

A

Abbreviates new drug applications for generic drugs
Required bioequivalence data.
Patent life extended by time it spends under FDA review

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

Orphan Drug Ammendment**

A

Ammends FDCA, provides incentives for development of drugs that treat disease with less than 200,000 pt’s in the USA

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

Major Legislation pertaining to PR: Ley 11 del 23 de junio del 1976

A

Creates a board for Bioequivalent for Medications, named by the Secretary of health of PR

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

Drug development and approval process

A 
Safety tests include: 
Acute toxicity
Subacute toxicity
Chronic Toxicity
Effect on reproduction
Carcinogenic potential
Mutagenic potential
Investigative toxicology
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

U.S. Pharmacopeia and Nation al Formulary

A

Establishes and regulates reference standards

Established by the Food and Drug Act of 1906 (Wiley/Heyburn Act)

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

Comprehensive drug abuse prevention and control act of 1970

A

Established the DEA
Established 5 schedules for drugs of abuse
Established penalties for misuse
Established quotas for manufacturing narcotics

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

Amendment that established the practice of pharmacy

A

Durham Humphrey Amedment of 1951

  • also established pharmacist physician relationship
  • Separate class for narcotics and physician registration numbers
  • Deals with legen drugs: prescription drugs
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Act responsible for premarket clearance for safety and efficacy as well as establishing modern drug review and approval procedures

A

Kefauver-Harris act

  • Requires animal data to be submitted before beginning human trials
  • **3 phases of clinical testing
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Act that caused review time to be sped up

A

Prescription Drug User Fee Act: Industry provides FDA funds in the form of fees to pay for positions and resources to review new drug applications

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

Molecular profile test of a drug

A

Receptor binding
Enzyme activity
Biotransformation enzymes

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

Cellular profile tests of a drug

A

cell culture systems

isolated organ prep

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

Systems/Disease model systems of a new drug

A 
Blood Pressure
Blood coagulation
Diuretic activity
Cardiac effects
CNS model systems
17
Q

Screening of drugs

A

How most new drugs are discovered
Specific set of procedures (in vivo and in vitro)
Bioassay (quantitative analysis) is used to establish relationship between dose and response

18
Q

How to make a new drug?

A

Synthesis de novo
Modifying the structure of an existing drug (SAR)
Purification of drugs from natural sources
Exploration of side effects of existing drugs

19
Q

Bioassay parameter EC50:

A

Concentration of an agonist where 50% of its max agonistic effect is observed

20
Q

Bioassay parameter IC50:

A

Concentration of an antagonist compound where 50% of its maximal antagonistic effect is observed

21
Q

Bioassay parameters ED50

A

Minimum required dose to show desired activity of drug in half the members of a tested population after a specific duration of time

22
Q

Bioassay parameters LD50

A

Represents the dose required to kill half the members of a tested population after a specific duration of time

23
Q 
Therapeutic index (bioassay parameters)
****Safety parameter in Experimental animals
A

Represents the ration of LD50 to ED50:

LD50/ED50=therapeutic index

24
Q

Therapeutic index in clinical medicine

A

Ratio between median toxic dose and median effective dose:

TD50/ED50=therapeutic index

25
Q

Animal studies: acute toxicity tests

A

One administration to each animal
Generation of dose-response curves
Appropriate pharm testing to determine ED50
Develop ways to determine absorption, excretion, distribution, and metabolism of chem

26
Q

Animal studies: Chronic toxicity tests

A

2 to 5 years

Multiple administrators or continuous exposure via food or water

27
Q

How to judge a drug?

A

Efficacy
Safety
Convenience
Cost

28
Q

What are possible drug reactions/toxicities/side effects?

A 
Allergic reactions
Blood dyscrasias
Hepatotoxicity and nephrotoxicity
Teratogenic effects
Behavioural toxicity 
Drug dependence and abuse
Carcinogenesis
Pharmacogenetic toxicities
29
Q

Blood dyscrasias as side effects:

A 
Agranulocytosis
Aplastic Anemia**
Hemolytic anemia
Thrombocytopenia
Clotting factors
30
Q

Behavioural toxicity examples

A

Suppression of normal anxiety
Reduced motivation
Adverse effects of moods

31
Q

Carcinogenesis

A

Delayed type of toxicity with latency of many YEARS***

32
Q

Pharmacogenic toxicities example

A

Malignant hyperthermia and anesthetics

33
Q

Controlled drugs (narcotics): Schedules

A 
I. No medical use
II. High potential for abuse (used medically with severe restrictions)
III. Medium potential for abuse
IV. Low potential for abuse
V. Low (still some) potential for abuse
34
Q

Schedule I drug

A

NO medical use
Considered highly addictive
78 opioids, 29 hallucinogens, depressants/stimulants (7)
Heroin, LSD, marijuana, quaaludes

35
Q

Class II drugs

A

Highly addictive with medical use
Morphine, cocaine, pentobarbital, methylphenidate
NO REFILLS, must have a DEA liscense
HIGHLY regulated

36
Q

Schedule III

A

Moderately addictive
Acetaminophen combos, codeine, nalorphine
No more than 5 refills/6mo’s

37
Q

Schedule IV

A

Drugs with limited addiction potential
Phenobarbital, benzo’s, chloral hydrate
NO refilling more than 5 times/6mo’s

38
Q

Schedule V

A

Drugs w/low addiction potential
Diphenoxylate (opioid)
May be sold w/out prescription by pharmacist

39
Q

Role of institutional review board (IRB)

A
  1. Ensures ethical acceptability of proposed research
  2. Reviews and approves research protocols involving humans
  3. Ensures the appropriateness of the informed consent document
  4. Reviews and approves the company’s/investigator’s IND document

Pharmacology (14 decks)

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