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Pharmacology > Exam 1 Mehta SG Part 2 > Flashcards

Exam 1 Mehta SG Part 2 Flashcards

( Drug History, History of the FDA and Modern FDA)

1
Q

What are the differences in pharmacoepidemiology

A

The differences in pharmacoepidemiology are….

-True randomization does not occur

  • The intervening decision-making and
    behavior of doctors and patients can
    alter the drugs’ effect
  • Outcomes are measured in terms of
    probabilities (or rates) of events
  • The magnitude of drug experience in the
    analysis is much larger than that of
    conventional pharmacology, ranging to
    millions of patients and millions of
    person-years of exposure
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2
Q

What is the margin of safety?

A

*Margin of safety
- The difference between the usual effective dose and the dose that causes severe or life-threatening (lethal) side effects

  • The margin of safety is LD50 ÷ ED50 (lethal dose divided by effective dose)
    If LD50 is 10 mg and ED50 is 2 mg then the margin of safety is only 5
    *10 ÷ 2 = 5
    o This means that the lethal dose is 
     only 5x the effective dose, which 
     may be predictive of a low margin of 
     safety in humans
  • Acceptable margin of drug safety in humans is > 2000
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3
Q

Define Margin of safety

A

*Margin of safety

  • The difference between the usual effective dose and the dose that causes severe or life-threatening (lethal) side effects
  • How safe it is
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4
Q

What is the acceptable Margin of drug safety in humans?

A

> 2,000

  • Acceptable margin of drug safety in humans is > 2000
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5
Q

Margin of safety equation

A

LD50 ÷ ED50

LD50= Letha dose
ED50= effectiveness dose

  • The margin of safety is LD50 ÷ ED50 (lethal dose divided by effective dose)
  • If LD50 is 10 mg and ED50 is 2 mg then the margin of safety is only 5
    *10 ÷ 2 = 5
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6
Q

Factors affecting drug cost and drug development

A

What Influences Drug Costs?
- Research & development costs including
the FDA approval process
- Complicated manufacturing process
-Extent of coverage and reimbursement
for the drug by third-party payers
(insurers)
- Desired profit margin of the
manufacturer
- Maximizing profits prior to patent
expiration
- Export to foreign countries
- Cost is dictated by the foreign
government or negotiated between
the manufacturer and that
government
- Typically drug costs overseas are
lower than cost in the U. S.

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7
Q

How long until you can submit an NDA?

A
  • NDA is submitted after the successful
    conclusion of clinical trials
  • After ~8 to 9 years of animal and
    human testing
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8
Q

What is NDA?

A

New Drug Application (NDA) Process

  • NDA is submitted after the successful conclusion of clinical trials
    -After ~8 to 9 years of animal and
    human testing
  • If FDA approves, the drug manufacturer can sell the new product as an exclusive proprietary drug
  • Patent on drugs lasts ~ 20 years after applying for the patent prior to Phase 1 of clinical testing
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9
Q

Clinical Phases of Drug Development
(short version)

A

Clinical Phases of Drug Development (FDA Approval)

  • Phase 1
    o Involves 20 – 100 people in the clinical
    trial
    o Tested for safety in healthy volunteers
  • Phase 2
    o Up to several hundred people in the
    clinical trial with the disease
    o Tested for short-term safety and
    effectiveness
  • Phase 3
    o Several hundred to several thousand
    people involved in the trial
    o Tested for safety, dosage,
    effectiveness, adverse events
  • Phase 4
    o Post-marketing surveillance for
    adverse event monitoring forever
  • The entire process can take 8 to 15 years and cost ~$1 to 2 billion
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10
Q

How long can the entire process of Clinical Phases of Drug Development Take?

A
  • The entire process can take 8 to 15 years and cost ~$1 to 2 billion
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11
Q

Clinical Phases of Drug Development
Phase 1

A
  • Phase 1
    o Involves 20 – 100 people in the clinical
    trial
    o Tested for safety in healthy volunteers
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12
Q

Clinical Phases of Drug Development
Phase 2

A
  • Phase 2
    o Up to several hundred people in the
    clinical trial with the disease
    o Tested for short-term safety and
    effectiveness
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13
Q

Clinical Phases of Drug Development
Phase 3

A
  • Phase 3
    o Several hundred to several thousand
    people involved in the trial
    o Tested for safety, dosage,
    effectiveness, adverse events
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14
Q

Clinical Phases of Drug Development
Phase 4

A
  • Phase 4
    o Post-marketing surveillance for
    adverse event monitoring forever
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15
Q

Conventional Pharmacology compared to to Pharmacoepidemiology

A
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16
Q

Define Pharmacoepidemiology

A
  • Pharmacoepidemiology is the study of drug outcomes as documented in observations of clinical data from large populations of typical patients receiving routine care
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17
Q

What is the importance of pharmacoepidemiology?

A

The importance of pharmacoepidemiology is highlighted by a

  • number of prominent drug withdrawals in recent years, such as Vioxx (anti-inflammatory drug) resulting in heart attack & stroke
    -Each of these withdrawals was
    preceded by severe or fatal adverse
    effects unrecognized or
    underappreciated at the time of
    approval
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18
Q

What is the original source of Quinine and what was it used to treat?

A
  • Bark of some trees contained quinine
  • Quinine is still used today as a drug of choice against MALARIA
  • The first specific drug used to treat an infectious disease
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19
Q

What is the original source of Synthesis of arsenicals and what was it used to treat?

A
  • synthesized arsenicals by attaching an arsenic atom to a carbon atom
  • It led to the use of arsphenamine (Salvarsan-first chemotherapeutic agent) to treat syphilis
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20
Q

What is the original source of Digitalis and what was it used to treat

A
  • Purple foxglove lead to isolation of digits

OLD: made tea to treat edema of cardiac

NOW: drug of choice for congestive heart failure

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21
Q

What is the original source of alkaloid morphine and what was it used to treat?

A

alkaloid morphine from opium & opium source is poppy plant

  • pain control
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22
Q

What is the original source of Caffeine and what was it used to treat?

A

Caffeine is extracted from the
- coffee plant, Coffea arabica

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23
Q

What comes from Atropa belladonna (Devil’s cherries) and what was it used to treat?

A

Two alkaloid substances isolated from plant

Atropine
- Dilates the pupils (medicinal use)

Scopolamine
Used for motion sickness

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24
Q

What is the original source of Atropine and what was it used to treat?

A
  • from atropa belladonna plant
  • Dilates the pupils (medicinal use)
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25
Q

What is the original source of Scopolamine and what was it used to treat

A
  • from Atropa belladonna plant
  • Used for motion sickness
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26
Q

What is the original source of and what Salicylic acid was it used to treat

A
  • Willow bark is a source of salicin, which is metabolized to salicylic acid in the body
  • Salicin and salicylic acid are chemical precursors to aspirin
  • Acetylsalicylic acid, also known as aspirin
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27
Q

What is Epinephrine and where is it produced?

A

Epinephrine, also known as adrenaline
- It is a hormone and a Neurotransmitter

  • Produced in
    - Some neurons of the CNS
    - The Chromaffin cells of the adrenal medulla
    from the amino acids, Phenylalanine and
    tyrosine
28
Q

What is produced by
- Some neurons of the CNS
- The Chromaffin cells of the adrenal medulla
from the amino acids, Phenylalanine and
tyrosine

A

Epinephrine, also known as adrenaline

29
Q

What is Acetylcholine (Act)

A
  • one of many neurotransmitters in the
    autonomic nervous system (ANS)
  • acts in both PNS & CNS
  • only neurotransmitter used in the motor
    division of the somatic nervous
  • in Cardiac tissue, acetylcholine neurotransmitters have an inhibitory effect which lowers heart rate
  • at neuromuscular junction in skeletal muscle it acts as an excitatory neurotransmitter
30
Q

in ____________ , acetylcholine neurotransmitters have an inhibitory effect which _____________

A
  • in Cardiac tissue, acetylcholine neurotransmitters have an inhibitory effect which lowers heart rate
31
Q

at _________________ in _________________ acetylcholine acts as an excitatory neurotransmitter

A

at neuromuscular junction in skeletal muscle it acts as an excitatory neurotransmitter

32
Q

What is Sulfa and where is it produced?

A
  • Sulfa is the active antibacterial portion of the red dye
    - Prontosil (red dye)- had no antibacterial
    properties.
    - chemical changes to Prontosil and became
    sulfanilamide
  • Sulfas are used today to treat infections of the urinary tract
33
Q

Origin of Penicillin

A

-discovered in mold known as penicillium notatum inhibited growth of staphylococcus aureus (a bacteria)
- named and name the active ingredient in SA penicillin

  • Penicillin was used during WWII in 1941, and saved many lives
34
Q

Durham - Humphery Act of 1952

A

Granted the FDA authority to determine which drugs may be sold without a prescription (OTC)

  • OTC are sold w/ lower dosage
35
Q

How does the FDA regulates drugs sold without a prescription.

A

FDA regulates drugs sold without a prescription

  • FDA reviews OTC drugs for misbranding and
    adulteration
  • FDA sets guidelines to which OTC drugs are safe
    and effective
  • FDA has authority to prevent sales and to
    withdraw OTC drugs from the market
36
Q

-FDA reviews OTC drugs for ___________ and
____________

A

FDA reviews OTC drugs for misbranding and
adulteration

37
Q

FDA sets __________ to which OTC drugs are _____
and ________

A
  • FDA sets guidelines to which OTC drugs are safe
    and effective
38
Q

FDA has authority to _________ ________ and to
___________ OTC drugs from the market

A

FDA has authority to prevent sales and to
withdraw OTC drugs from the market

39
Q

How does the FDA regulate supplemental product manufacturers

A
  • To test products for purity
  • To assure that products do not contain
    contaminants
  • To verify that contents within package matched
    labeling information
40
Q

What does the FDA do?

A

The FDA is responsible for…

1)protecting the public health
- by assuring the safety, efficacy and security of drugs, medical devices, food supply, cosmetics & products that emit radiation

2) advancing the public health
- by helping to speed innovations that make medicine more effective, safer and more affordable. get the public accurate science based info

3) Regulating
- Manufactures , Marketing and distribution of tobacco to protect the public heath & reduce use by minors

4) Significant role in Nation’s counterterrorism capabilities
- by ensuring the security of food supply and fostering Development of medical products to responds to public heath threats

41
Q

The FDA is responsible for…
Name first responsibility

A

1) protecting the public health
- by assuring the safety, efficacy and security of drugs, medical devices, food supply, cosmetics & products that emit radiation

42
Q

The FDA is responsible for…
Name Second responsibility

A

2) advancing the public health
- by helping to speed innovations that make medicine more effective, safer and more affordable. get the public accurate science based info

43
Q

The FDA is responsible for…
Name third responsibility

A

3) Regulating
- Manufactures , Marketing and distribution of tobacco to protect the public heath & reduce use by minors

44
Q

The FDA is responsible for…
Name fourth responsibility

A

4) Significant role in Nation’s counterterrorism capabilities
- by ensuring the security of food supply and fostering Development of medical products to responds to public heath threats

45
Q

What is ANDA

A

Abbreviated New Drug Application
- ANDA is an application for a U.S. generic drug approval for an EXISTING LICENSED medication or approved drug

  • not required to include trial data to establish safety and effectiveness
  • Instead demonstrate their products is bioequivalent
    Bioequivent = Same effectiveness
46
Q

T/F. for an ANDA the applications require preclinical (animal and in vitro) and clinical (human) trial data to establish safety and effectiveness?

A

FALSE

ANDA they are

  • not required to include trial data to establish safety and effectiveness
  • Instead demonstrate their products is bioequivalent
    Bioequivent = Same effectiveness
47
Q

what application is for a U.S. generic drug approval for an EXISTING LICENSED medication or approved drug

A

ABBREVIATED NEW DRUG APPLICATION (ANDA):

48
Q

general phases of drug development

A
  • Synthesis or discovery of new chemicals from the test tube or plant(s)
  • Safety evaluation in animals and humans
  • Effectiveness evaluation in humans
  • Review of new drug application
  • Post-marketing surveillance to report all adverse effects
49
Q

why should we study pharmacology as audiologists

A

There are ~2,000 drugs and > 400 side effects that could impact the audiologic/vestibular system, it’s evaluation/management, i.e.,

Obtaining an accurate case history and/or test results, which might lead to a misdiagnosis of auditory-vestibular problems

50
Q
A
51
Q

Short-term toxicity testing

A
  • Testing in animals
  • General profile screen in mice
  • Determination of the lethal dose = LD50
    - Dose of a drug that kills 50% of the total
    number of mice that receive it
  • Determination of effectiveness dose = ED50
    - Dose of a drug that causes an effect in
    50% of the total numbers of mice that
    received it
52
Q

Long-term toxicity

A

AKA Chronic Toxicity Studies

  • Daily dosing to rats and dogs from 3 months to 2 years
  • Observe for toxicities, evaluate blood chemistries
  • Sacrifice the animal, then evaluate histopathology
  • Many toxic effects appear only after repeated dosing over many months or years
    -That is the reason why post approval
    regulation is required
53
Q

Investigational New Drug Application (IND)

A
  • Submitted if the drug has an impressive margin of safety in mice
  • Submitted if a drug lacks long-term toxicities
  • Submitted if a drug does not cause cancer, reproductive effects, or birth defects
  • A 30-day approval by the FDA (usually takes longer)
54
Q

Clinical Phases of Drug Development (FDA Approval)

Phase 1 (longer version)

A
  • Begins immediately after IND approval
  • 20-100 healthy volunteers
  • evaluates safety of the drug in humans
  • Determine what the does does w/drug
  • Establishes the dose of toxicity
  • Trial lasts for several months
  • Non-blinded trials
    • Participant and investigator are both aware of what is being administered
55
Q

Clinical Phases of Drug Development (FDA Approval)

Phase 2 (longer version)

A
  • Given to patients having the condition for which the drug is intended
  • several hundreds of patients
  • Short term - effectiveness and safety
  • several months to two years
  • Single- blind trial
    - drug evaluated against placebo
    - Participants are unaware what they are receiving
56
Q

Clinical Phases of Drug Development (FDA Approval)

Phase 3 (longer version)

A
  • Several hundred to several thousand
  • Confirms drug safety, dosage & effectiveness
  • 1- 2 years
  • Randomized, Double blind
    - Participant nor investigator knows which groups is the subject
  • NDA is submitted after the successful conclusion of clinical trials
57
Q

Clinical Phases of Drug Development (FDA Approval)

Phase 4 (longer version)

A

Post - Marketing Surveillance
- After FDA approval
- Drugs is monitored for the reminder of its life span
- A drug can be pulled off market if new toxins are uncovered.

58
Q

Treatment use of investigational drugs occurs when?

A

Treatment use of investigational drugs
Occurs during review of the NDA

59
Q

Expanded access (compassionate use protocol)

A
  • A drug can be used under certain conditions prior to FDA approval for patients who are not in the drug’s clinical trial, such as
    - Desperately ill patients
    - When the side effects are not an issue
    - No comparable alternative drug is available
60
Q

Right - to - Try law

A
  • Drugs used after phase 1 clinical trails but before FDA approval
  • used for desperately ill patients with no other alternative
61
Q

What study Pharmacology?

A
  • There are ~2,000 drugs and > 400 side effects that could impact the audiologic/vestibular system, it’s evaluation/management, i.e.,
  • Adverse drug reactions that can affect auditory-vestibular systems
  • Audiologists need to have the knowledge base to recognize and prevent an ototoxic effect of a chemical
  • Audiologists also need to have the knowledge base to recognize and manage an ototoxic effect once it has occurred
62
Q

Transmembrane Receptors

A

The ligand has to match the cell receptor to be able to enter. lock & key

63
Q

Life Cycle of Drug Approval

A
  • Drug Discovery phase:
    o This phase produces a new molecule
    o First patents are filed at this stage and
    granted several years later
  • Drug Development phase
    o The process requires that biological
    characterization and toxicology animal
    studies be conducted prior to filing an
    Investigational New Drug (IND) application
    o An IND is required at the start of clinical
    (human) trials (Phase I to III)
    o At the conclusion of successful clinical trials,
    the drug company files a New Drug
    Application (NDA), which is reviewed by the
    FDA
  • Post Approval Regulation
    o Once approved, a drug must be monitored
    for the remainder of its life span (Phase IV)
    o The first of the drug’s patents expires 20
    years after its application
    o Abbreviated New Drug Application (ANDA)
    can be filed before expiration of original
    patent
    o Once the patent expires, generic versions
    can become available
64
Q

Life Cycle of Drug Approval
Post Approval Regulation

A
  • Post Approval Regulation
    o Once approved, a drug must be monitored
    for the remainder of its life span (Phase IV)
    o The first of the drug’s patents expires 20
    years after its application
    o Abbreviated New Drug Application (ANDA)
    can be filed before expiration of original
    patent
    o Once the patent expires, generic versions
    can become available
65
Q

Life Cycle of Drug Approval
Drug Development phase

A
  • Drug Development phase
    o The process requires that biological
    characterization and toxicology animal
    studies be conducted prior to filing an
    Investigational New Drug (IND) application
    o An IND is required at the start of clinical
    (human) trials (Phase I to III)
    o At the conclusion of successful clinical trials,
    the drug company files a New Drug
    Application (NDA), which is reviewed by the
    FDA
66
Q

Life Cycle of Drug Approval
Drug Discovery phase:

A
  • Drug Discovery phase:
    o This phase produces a new molecule
    o First patents are filed at this stage and
    granted several years later
67
Q

Drug Patents

A

When patents expires other companies can market the generic drug under a trade name of their choose
ex: coke
Pepsi both trade name

Pharmacology (9 decks)

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