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PCOL 310 > PCOL 310 > Flashcards

PCOL 310 Flashcards

1
Q

Federal Food, Drug, and Cosmetic Act of 1938

A

-Required manufacturers demonstrate safety of new drugs prior to marketing
-Allowed FDA to inspect manufacturing facilities
-Defined the following key terms: drug, device, cosmetics and labeling

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2
Q

Durham-Humphrey Amendment of 1951

A

distinguishes prescription from non-prescription

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3
Q

Kefauver-Harris Amendment of 1962

A

-required that manufacturers prove the effectiveness of drug products before they go on the market, and report any serious side effects
-required that evidence of effectiveness be based on adequate and well-controlled clinical studies conducted by qualified experts
-gave FDA 180 days to approve a new drug application

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4
Q

Orphan Drug Act of 1983

A

-drugs intended to treat rare diseases and conditions
-provides pharmaceutical manufacturers tax and licensing incentives to develop them

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5
Q

food

A
  • articles used for food or drink for man or other animals
  • chewing gum
  • articles used for components of any such article.
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6
Q

drug

A
  • Articles recognized in the official USP/NF or Homeopathic Pharmacopoeia, or any supplement to any of them
  • Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals
  • Articles other than food intended to affect the structure or function of the body of man or other animals

(no destinction b/w prescription vs. non-prescription & human vs. animal)

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7
Q

Waxman Hatch Amendment of 1984-

A

Drug price Competition and patent term restoration act
-Streamlined generic drug approval process to make them more readily available
-created certain market and patent exclusivity periods for both branded and generic drug companies

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8
Q

Labeling

A

All labels and other written, printed, or graphic matter on any container or wrapper or material accompanying the product
-Package insert
-drug advertisement
-information in publications ( PDR)
-Promotional materials such as newsletter and literature

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9
Q

GMP

A

Good manufacturing practice
-Applies to manufacturers, not pharmacies
-Drugs subject to GMP are selected based on medical importance,market share, number of similar products in the marketplace, and previous compliance record of the manufacturer.
- Every two years manufacturers must register with the FDA to be inspected.

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10
Q

Non prescription drug labeling

A

-Display panel
-Must have detailed usage and warning info so consumers can properly choose and use the products

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11
Q

Principal Display Panel

A

-Panel of the label that is most likely to be displayed, presented, shown or examined by the end user

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12
Q

Commercial Container Label

A

for the health care professional and not the consumer

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13
Q

Drug listing act of 1972

A

Required manufacturers to provide the FDA with a current list of all drugs manufactured, prepared, propagated,compounded, or processed by it for commercial distribution

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14
Q

NDC code

A

1234-5678-90
1234= manufacturer
5678=drug
90=package

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15
Q

Seizure

A

The physical isolation of a drug while FDA or state agency files civil lawsuit
-What drugs can the FDA seize?
-Mis branded or adulterated

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16
Q

Recall

A
  • The correction or removal, and notification to the company, of a product that is in violation of the law.
    -3 levels of recall
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17
Q

cosmetic

A

Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into , or otherwise applied on the human body, or any part thereof for cleansing, or altering the appearance.
-Articles intended for use as a component in any such articles, not including soap

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18
Q

Dietary Supplement

A

A product taken by mouth that is intended to supplement the diet and contains one or more dietary ingredients, Including
-Vitamins
-Minerals
-Herbs or other botanicals
-amino acids
-other substances found in the human diet such as enzymes
-Must be labeled as such and must not be represented as conventional food or as the sole item of a meal of the diet
-Conventional foods are foods that are not dietary supplements (Nutrition facts vs supplement facts panel)

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19
Q

Device

A

An instrument, apparatus, machine, contrivance, implant, in vitro Reagent, or other similar or related article, including any part component or accessory intended to diagnose or treat a disease

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20
Q

label

A

display of written material on the products container or on the outside container or wrapper

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21
Q

class 1

A

reasonable probability that the use of, or exposure too a violative product will cause serious adverse health consequences or death

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22
Q

class 2

A

Use of or exposure too may cause a temporary or medically reviserable adverse health consequence,or where the probability of serious health consequences is remote.

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23
Q

class 3

A

Use or exposure to the product is not likely to cause serious adverse health consequences

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24
Q

IND

A

Investigational New drug application
-Evaluated by: Office of new drugs (OND) & Center for Drug Evaluation and Research (CDER)

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25
Q

Institutional Review Board (IRB)

A

-“Pay to Play”
-Support timely review
-Options for waivers/reduction/refunds
-Applicable for small businesses, first time applicants

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26
Q

Risk Evaluation and Mitigation Strategies (REMS)

A

-FDA can require REMS for certain medications with serious safety concerns to ensure benefits outweigh the risks

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27
Q

Standard FDA review path

A

12 months

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28
Q

Priority FDA review path

A

8 months
-Demonstrate that the drug or biologic has potential to significantly improve safety of effectiveness of treatment, diagnosis, prevention of serious/life threatening conditions
-FDA has 60 days to review an NDA

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29
Q

Abbreviated New Drug Application

A

-Process where generic products are approved after expiration of patent held by innovator company
-Requires proof that generic’s pharmacokinetics, bioavailability and clinical activity are similar to the innovator product

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30
Q

Supplemental new drug application SNDA

A

-Submitted after the NDA approval
- Covers change in synthesis, production procedures, manufacturing locations, indications

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31
Q

Agencies responsible for drug advertising

A

-FDA regulates prescription drug advertising
-Federal Trade Commission: regulates non prescription drugs under the federal trade commission act

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32
Q

Non clinical testing objectives

A

Does compound or molecule work
How can we deliver it to the right cell/tissues/ organs
Is it safe
Can we manufacture it ensuring safety, practicality, stability

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33
Q

Types of Non clinical trial studies

A

In Vitro- Controlled enviornment outside living organism
In Vivo- Using a whole, live living organism
In Silicio- on a computer

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34
Q

Pharmacodynamics studies

A

method of action vs mode of action

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35
Q

Mechanism

A

Biochemical interaction through which a drug substance produces a pharmacological effect

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36
Q

Mode

A

describes functional or anatomical changes at the cellular level resulting from the exposure of a living organism to a substance- action on specific receptors or enzymes

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37
Q

Pharmacokinetic studies

A

Determine the highest and lowest concentration in the body after med administration, movement of drugs within the body

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38
Q

ADME

A

absorption, distribution, metabolism, excretion

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39
Q

Good Laboratory Practice

A

The batches of the active ingredient must be qualified and produced according to the GMP guidelines

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40
Q

CMC

A

Chemistry, manufacturing and control. Term used in the context of production and quality control of drugs or drug candidates.

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41
Q

Non-clinical outcomes that can STOP development

A

-Discovery of organ toxicity
-Identification of poor pharmacokinetic properties

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42
Q

IACUC

A

Institutional Animal Care and Use committee.
-must review all animal experiment protocols

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43
Q

AAALAC

A

Association for assessment and accreditation of laboratory animal care
-Non-profit organization that accredits research facilities for compliance with the guide

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44
Q

Types of Toxicity studies

A

-Local tolerance studies
-genotoxicity studies
-carcinogenicity studies
-reproduction toxicity

45
Q

No Observed Adverse Effect Level (NOAEL)

A

The highest dose, among doses tested in a study, that demonstrates no significant difference from effects measured in control animals.

46
Q

Minimal Anticipated Biological Effect Level (MABEL)

A

Used in establishing first human dose

47
Q

IND purpose

A

-Notifies regulators of intent to begin clinical studies in US
-Provides preclinical data indication that the drug is reasonably safe to administer to humans
-provides information about manufacturing process and chemistry background
-Describes the initial clinical study being proposed
-Provides insurance that an Institutional review board will approve the study before it begins

48
Q

Commercial IND

A

-Pharmaceutical companies whose ultimate goal is to obtain marketing approval for new products

49
Q

Research IND

A

-(Non commercial) submitted by physicians who initiate and conduct an investigation

50
Q

Product development (Clinical Investigation) IND

A

submitted by corporate entity or physician who both initiates and conducts the investigatio

51
Q

Clinical treatment (Expanded Access INDS)

A

Use of an IND outside of a clinical trial by patients, with serious or life treating conditions and no comparable or satisfactory alternative therapy exists, who do not meet enrollment criteria for the clinical trial process

52
Q

Criteria for expanded access programs

A

1) Presence of life threatening condition with no comparable alternative treatment
2) Potential benefit to patient justifies the risk
3)Use of the IND will not interfere with it clinical investigative process or compromise its development

53
Q

Right to Try act

A

Permits/allows eligible patients to have access to eligible investigational drugs

54
Q

IND module contents

A

Module 1: Administrative info
Module 2: Summaries
Module 3: Quality
Module 4: Non clincal studies reports
Module 5: Clinical study reports

55
Q

Clinical Hold

A

an order issued by the FDA to the sponsor of an IND to delay a proposed clinical investigation or suspend an ongoing clinical investigation

56
Q

-vastatin

A

Cholesterol lowering

57
Q

-oxetine

A

anti depressant

58
Q

-sartan

A

Lowers BP

59
Q

-afil

A

erectile dysfunction

60
Q

-lukast

A

asthma

61
Q

-azepam

A

anti anxiety

62
Q

-coxib

A

anti-inflammatory

63
Q

-formin/glitazone

A

Diabetes

64
Q

-prazole

A

acid reducer

65
Q

-vir

A

anti virals

66
Q

When is IND not required?

A
  • Certain research involving marketed drug products
  • bio availability or bio equivalence drugs ( using unapproved versions or approved drugs)
67
Q

What can be patented?

A

-chemical substance, pharmaceuticals
-processes, methods, uses
- products, devices, systems

68
Q

Five year exclusivity period

A

FDA gives exclusivity period for new chemical entity (NCE), during which no other company can submit a ANDA

69
Q

FDA vs Patent Protection

A

FDA=5 years
Patent Protection= 20 years

70
Q

FDA orange book

A

where manufacturers list their patents

71
Q

Patent and Utility Models

A

New inventions

72
Q

Copy Right

A

Original creative or artistic forms
-automatically exists

73
Q

Trademarks

A

Distinctive ID of products or services

74
Q

Registered design

A

external appearance

75
Q

Trade secrets

A

Valuable information not known to the public

76
Q

NDA: A request to market the drug

A

-clinical safety and efficacy data
-clinical pharmacokinetic data
-non clinical pharmacology/toxicology data
-chemistry data
-Package labeling
-administrative information (ie patent information, debarment certification)

77
Q

Types of NDA

A

-New Molecular entity (NME )
-New active ingredient
-New dosage form
-New combination
-New formulation or new manufacturer
- New indication, same manufacturer( No longer used)
-Drug already marketed, but without approved NDA
-Rx to OTC

78
Q

Efficacy Supplement

A

defined based on the type of change that is being made, not the type of data the supplement contains
-sponsor should submit a redline version of the proposed labeling so the FDA can see the proposed changes

79
Q

Priority Review

A

Drug product has the potential to provide
- S and E therapy where there is no satisfactory alternative
-A significant improvement compared to marketed products

80
Q

Accelerated Approval

A

allows approval based on a surrogate endpoint

81
Q

Fast- Track Designation

A

for new drugs intended to treat serious or life threatening conditions, demonstrate the potential to address unmet medical needs

82
Q

Rolling Submission

A

A drug company can submit completed sections of the NDA review by FDA, instead of waiting until the entire application is done

83
Q

Breakthrough Designation

A

FDASIA’s designation for drugs that may treat a serious or life threatening condition

84
Q

PDUFA vs the program

A

applies to all NME’s, NDA’s and original BLA’s (fiscal years 2013-2017)
Modifications-
-additional 2 months added to the review period
- Priority 6 months= 8 months standard 10 months = 12 months
- More frequent communication with the applicant

85
Q

Drug approval process 1-5

A

1) pre non clinical animal studies
2) IND application
3) Phase 1 20-80 applicants testing for safety
4) Phase 2 100’s of volunteers testing for efficacy
5) Phase 3 100 to 1000 volunteers, gather biological info, uses drug in combination of other drugs

86
Q

Drug approval process 6-12

A

6) Review meeting
7) NDA application
8-9) Application reviewed
10)Drug labeling
11) facility inspection
12) Drug approval or denial

87
Q

Clinical Investigation

A

any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.

88
Q

sponsor

A

person who takes responsibility for and initiates clinical investigation

89
Q

Sponsor- investigator

A

The person who both initiates and conducts a clinical investigation
the drug is administer/dispensed under their direction

90
Q

IND process

A

Day 0-7 : receipt and assignment of reviewers
Day 8-27: review and safety meetings
Day 25-30: saftey decision and notification

91
Q

How do drugs get their names?

A

Chemical name: Describes atomic or molecular structure
generics- assigned by U.S adopted names
brand- developed by the company requesting approval of that drug

92
Q

An expanded access use IND would be most likely to be granted where:a) An approved drug has demonstrated safety and the patient is in imminent life threatening stages of an illness.b) An unapproved drug has demonstrated efficacy and there are some drugs available to treat the patient’s condition c) An unapproved drug has some demonstrated safety and efficacy and the patient is in life threatening stages of an illness d) An unapproved drug has some demonstrated safety and efficacy and the patient is already enrolled in the clinical studies for the drug.

A

C

93
Q

During phase 1 of a clinical trial for a drug under a Investigational New Drug Application a) The drug is tested on a large number of animals to determine efficacy b) The drug is tested on a large number of animals to determine safety c) The drug is tested on a limited number of healthy patients to determine efficacy d) The drug is tested on a limited number of healthy patients to determine safety

A

D

94
Q

Under the federal FDCA, a drug a) “Caution: Federal law prohibits dispensing without prescription” or “Rx Only.”b) Is a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.c) Is a product intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human bodyd) Is a product where the container or labeling of which bears the trademark, trade name of a drug manufacturer

A

B

95
Q

Is caffeine classified as a:a) Drug b) Supplement c) Food

A

a) drug

96
Q

IS infant formula classified as a) Drug b) dietary supplement c) food

A

b) dietary supplement

97
Q

GxP purpose

A

Good (Anything) practice
-guidelines are there to ensure a product is safe and meets its intended use, guides quality manufacture in regulated industries
Central aspects: Traceability, accountability

98
Q

Traceability

A

the ability to reconstruct the development history of a drug or medical device

99
Q

accountability

A

the ability to resolve who has contributed what to the development and when

100
Q

True or False: The primary objective of GLP’s are to ensure scientific validity and good science in the non-clinical testing of compounds

A

FALSE does not ensure good science… it does ensure the uniformity, consistency, reliability, reproducibility, quality and integrity of chemical non-clinical safety tests

101
Q

true or false: GMP guidelines provide prescriptive instructions on how to manufacture products

A

FALSE they are a series of general principles and minimum requirements that must be observed during manufacturing

102
Q

GCP enforces which of the following aspects of clinical trials?-ethical aspects of a clinical study-standards on how clinical trials should be conducted-the roles and responsibilities of clinical trial sponsors and clinical research investigators-all of the above

A

all of the above

103
Q

detailing

A

face to face promotional activities, representatives typically visit prescribers to pitch their drug (ex: meals, gifts )

104
Q

samples

A

providing free medications samples to prescribers

105
Q

educational and promotional meetings

A

leaders discuss the use of drugs

106
Q

indirect marketing

A

sponsorships and grants

107
Q

Who regulates advertisement to consumers?

A

-FTC regulates ads or OTC drugs
-FDA regulates ads for prescription drugs, medical devices, lasers and contact lenses

108
Q

Direct to consumer (DTC) advertising

A

any promotional effort by pharmaceutical company to present prescription drug info to the general public through the law media.

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