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DDD > Lecture 1 > Flashcards

Lecture 1 Flashcards

1
Q

A chemical substance that affects living organisms and is used by clinicians to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition.

A

Drug

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2
Q

The ideal drug is a hypothetical concept that encapsulates the desired qualities of a medication. While no drug can perfectly meet all these criteria, these properties serve as a benchmark for drug development and evaluation.

A
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3
Q

Ideal Properties of Drugs

A
  1. Efficacy and Potency
  2. Safety and Selectivity
  3. Pharmacokinetics
  4. Stability and Compatibility
  5. Cost-Effectiveness
  6. Convenience
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4
Q

Refers to blood entry in Pharmacokinetics

A

Absorption

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5
Q

Refers to drug processing mainly by the liver

A

Metabolism

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6
Q

Refers to elimination through the kidneys, lungs or biliary exretion

A

Excretion

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7
Q

The ideal drug would be highly effective, safe, selective, and convenient, while also being affordable and easy to administer. While this is an ambitious goal, drug development efforts strive to create medications that come as close as possible to these ideals.

A
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8
Q

Out of every 10,000-15,000 new compounds identified during discovery,
FIVE are considered safe for testing in human volunteers. Only ONE of these compounds is typically APPROVED as a marketed drug.

A
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9
Q

How many years will it take for drug discovery and pre-clinical trial?

A

3-6 years

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10
Q

How long will it take for clinical trials (phase I to III)

A

6-7 years

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11
Q

How long does FDA Review, Manufacturing, and Phase IV Post-Approval take?

A

0.5 to 2 years

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12
Q

biological processes underlying a disease to identify potential targets, such as proteins or enzymes

A

Disease Understanding

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13
Q

targets are validated to ensure that interfering with them will likely have a therapeutic effect

A

Target Validation

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14
Q

Millions of compounds are screened to identify those that interact with the target

A

Screening

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15
Q

The most promising compounds (hits) are further refined to improve their potency, selectivity, and pharmacokinetic properties.

A

Hit-to-Lead Optimization

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16
Q

It is a critical phase in the process of developing a new drug. It involves extensive testing and evaluation of the compound to ensure its safety and efficacy before it can be tested in humans.

A

Pre-Clinical Research

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17
Q

“In living”

Experiments are performed on living organisms, such as animals or humans.

Examples: Testing a new drug on rats to assess its efficacy and safety.

A

In Vivo

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18
Q

“In glass”

Experiments are performed outside of a living organism, often in a laboratory setting, using artificial conditions.

Examples: Culturing cells in a petri dish to study their behavior.

A

In Vitro Testing

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19
Q

In Vivo Testing

A

Toxicity studies
Pharmacologic studies

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20
Q

In Vitro Testing Studies

A

Cell-Based Assays
Biochemical Assays

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21
Q

The application for clinical testing in humans, which is submitted to the FDA.

A

Investigational New Drug (IND) Application

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22
Q

Identifies unexpected side effects or adverse events that may not have been detected in clinical trials.

A

Post-Market Surveillance

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23
Q

Ensures that the drug’s labeling accurately reflects its benefits and risks.

A

Labeling Updates

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24
Q

Explores the drug’s effectiveness in different patient populations or for new indications.

A

Efficacy Assessment

25
Q

Compares the drug’s effectiveness to other available treatments.

A

Comparative Effectiveness Research

26
Q

Evaluates the drug’s long-term safety profile, especially for drugs used for chronic conditions.

A

Long-Term Safety Assessment

27
Q

Most drug candidates fail during development due to safety, efficacy, or regulatory issues.

A

High Failure Rates

28
Q

The process is expensive and time-consuming, often taking over a decade to complete.

A

Cost and Time

29
Q

Protecting intellectual property is
crucial to recoup investments and maintain market exclusivity.

A

Intellectual Property

30
Q

Navigating complex regulatory
requirements can be challenging.

A

Regulatory Hurdles

31
Q

Typical duration of drug discovery

A

10-15 years

32
Q

Average Cost for Drug Development

A

$1 Billion +

33
Q

It is the ability of the drug to exhibit its maximum effect

A

Efficacy

34
Q

It refers to the concentration or strength of the drug that produces an effect

A

Potency

35
Q

It refers to the drug having a specific target or site of action

A

Selective

36
Q

The ability of the drug to be stable in different environments (longer shel life)

A

Stability

37
Q

Drugs should be compatible with other substances

A

Compatibility

38
Q

Drivers of Drug Development

A

Unmet Medical Needs
Market Potential
Scientific Advancements
Competitive Landscape
Intellectual Property

39
Q

It is an In Vivo test performed to test if the lead compound is harmful (increasing dose of lead compound is administered to subjects

A

Toxicity Studies

40
Q

It is an In Vivo test testing for the therapeutic effect of the product.

A

Pharmacologic Studies

41
Q

It is an In Vitro test used to test certain compounds in artificial environments

A

Cell-Based Assays

42
Q

It is an In Vitro test that uses enzymes/proteins to evaluate

A

Biochemical Assays

43
Q

IND Application must include:

A
  • Animal Pharmacology and toxicity data
  • Data from any prior human research
  • Clinical Protocols for proposed human studies
  • Principal Investigators Information
    Manufacturing Information
44
Q

Purpose of Phase I Clinical Trials

A

Safety, Tolerability, Pharmacokinetics

45
Q

Purpose of Phase II Clinical Trials

A

Efficacy, Safety, Optimal Dosage

46
Q

Purpose of Phase III Clinical Trials

A

Efficacy, Safety in a large population

47
Q

NDA data for evaluation:

A
  • Proposed Labeling
  • Safety Updates
  • Drug Abuse Information
  • Patent Information
  • Data from studies conducted outside US
  • Institutional Review Board compliance information
  • Directions for use
  • Potential Interactions with other medications
48
Q

Content of IND

A

Pre clinical data and clinical trial protocols

49
Q

Content of NDA

A

Pre clinical and Clinical data
Manufacturing information
Labeling

50
Q

Key Challenges in Drug Discovery

A

High Failure Rates
Cost and Time
Intellectual Property
Regulatory Hurdles

51
Q

This includes the prevalence of the disease, the target patient population, and the potential pricing and reimbursement landscape.

A

Market Potential

52
Q

New discoveries about disease mechanisms or the identification of promising drug targets, can provide a strong rationale for drug development.

A

Scientific Advancements

53
Q

The availability of existing treatments and the potential for new competitors, is assessed to determine the potential for a new drug to gain market share.

A

Competitive Landscape

54
Q

Number of Volunteers in Phase I Clinical Trial

A

20 to 100

55
Q

Number of Volunteers in Phase II Clinical Trial

A

100 to 500

56
Q

Number of Volunteers in Phase III Clinical Trial

A

1,000 to 5,000

57
Q

Drug Development Process:

A

Drug Discovery
Pre-Clinical Research
Clinical Trials
Post-approval Monitoring

58
Q

Examples of animals used in In Vivo Testing

A

Mice
Rats
Rabbits

DDD (9 decks)

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