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DDD > pre-clinical testing > Flashcards

pre-clinical testing Flashcards

1
Q

Involves experiments conducted on living organisms, typically animals, to observe the effects of a drug in a whole-body system.

A

In Vivo Testing

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2
Q

Involves experiments conducted on living organisms, typically animals, to observe the effects of a drug in a whole-body system.

A

In Vivo Testing

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3
Q

Involves experiments performed on isolated cells, tissues, or organs outside of a living organism, providing a simplified model for studying drug effects.

A

In Vitro Testing

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4
Q

Regulatory Requirements for in vivo Studies

A

• Global Regulatory Bodies
• Ethical Considerations
• Standardized Protocols

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5
Q

The primary agency responsible for regulating animal use in drug
development in the Philippines

A

Bureau of Animal Industry (BAI), under the Department of Agriculture (DA)

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6
Q

The BAI oversees and implements the _____, which provides the legal framework for the humane treatment of animals used in research and development.

A

Animal Welfare Act of 1998 (Republic Act No. 8485)

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7
Q

Other agencies that may be involved
in regulating animal use in drug development in the Philippines

A

Department of Health (DOH)

Philippine Council for Health Research and Development (PCHRD)

Institutional Animal Care and Use Committees (IACUCs)

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8
Q

They may be involved in setting standards for the use of animals in
biomedical research.

A

Department of Health

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9
Q

They may provide guidelines and ethical review for research involving animals.

A

Philippine Council for Health Research and Development (PCHRD)

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10
Q

They are established within research
institutions to review and approve animal use protocols.

A

Institutional Animal Care and Use Committees (IACUCs)

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11
Q

They play a crucial role in the development and testing of new
drugs.

A

Animal models

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12
Q

The different rodent models

A

Mice
Rats
Guinea Pigs

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13
Q

Small size, short lifespan, easy to
breed and handle.

A

Mice

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14
Q

Larger size, longer lifespan, more
robust physiology.

A

Rats

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15
Q

Similar to humans in terms of vitamin C requirements.

A

Guinea Pigs

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16
Q

Non-Rodent Models

A

Primates
Pigs
Dogs
Rabbits

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17
Q

Closest to humans in terms of physiology and genetics, valuable for studying diseases like HIV and Alzheimer’s

A

Primates

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18
Q

Used for studying organ transplantation and cardiovascular research, similar size and anatomy to humans.

A

Pigs

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19
Q

Large animal models for studying cancer, diabetes, and cardiovascular diseases, long lifespan allows for chronic
studies.

A

Dogs

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20
Q

Used for studying reproductive and developmental toxicology, convenient size and relatively low cost.

A

Rabbits

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21
Q

They are widely used in drug research due to their physiological similarities
to humans.

A

Rats

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22
Q

Understanding different rat strains is crucial for selecting the most
appropriate model for specific research questions.

A
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23
Q

They are are an albino strain characterized by their white fur and pink eyes.

A

Wistar rats

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24
Q

They are known for their rapid growth and adaptability, making them suitable for various research purposes.

A

Wistar Rats

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25
Q

They are a popular strain known for their docile nature, rapid growth rate, and high reproductive rate.

These qualities make them suitable for various studies, including toxicology, pharmacology, and safety testing.

A

Sprague Dawley Rats

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26
Q

Their consistent physiology allows for reliable data collection and interpretation.

Researchers often use these rats for general toxicity testing and to evaluate drug efficacy.

A

Sprague Dawley

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27
Q

These rats are known for their hooded coat pattern, featuring a darker, pigmented area on the head and shoulders.

A

Long-Evans

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28
Q

This strain is also recognized for its relatively larger size compared to other commonly used rat strains.

A

Long-Evans

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29
Q

rats are often used in behavioral research due to their well-documented behavioral patterns and responses.

They are also valuable models for studying neurological disorders
and drug-induced behavioral changes.

A

Long-Evans

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30
Q

These rats are genetically predisposed to hypertension, characterized by elevated blood pressure.

These rats are commonly used in research on cardiovascular
diseases, including stroke, heart failure, and hypertension.

A

Spontaneously Hypertensive Rats (SHR)

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31
Q

They are valuable models for evaluating new drugs for hypertension and other cardiovascular disorders.

Their sensitivity to hypertension makes them particularly useful
for testing the efficacy of antihypertensive drugs.

A

Spontaneously Hypertensive Rats

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32
Q

These rats are genetically predisposed to
obesity and type 2 diabetes.

These rats are characterized by their distinctive white fur and tendency to develop insulin resistance.

A

Zucker Diabetic Fatty (ZDF) rats

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33
Q

ZDF rats are valuable models for studying diabetes, obesity, and related metabolic disorders.

Researchers utilize ZDF rats to evaluate the efficacy and safety of new drugs for managing diabetes and obesity.

A
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34
Q

Considerations in Rat Selection

A

• Genetic Background
• Age and Sex
• Health Status
• Environmental Factors
• Ethical Considerations

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35
Q

Consider the specific genetic makeup of the rat strain, as it can influence susceptibility to diseases and drug responses.

A

Genetic Background

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36
Q

It can significantly affect physiology and drug metabolism, influencing experimental outcomes.

A

Age and Sex

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37
Q

Ensure rats are healthy and free from pre-existing conditions that might confound research findings.

A

Health Status

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38
Q

Controlled environmental conditions, including _____, are crucial for consistent results.

A

temperature, humidity, and light cycles

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39
Q

It is paramount, ensuring humane treatment and minimizing stress for accurate research outcomes.

A

Animal welfare

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40
Q

These are essential in evaluating the safety and potential side effects of new pharmaceutical compounds.

These studies are conducted on living organisms, typically animal models, to assess the drug’s impact on various physiological systems.

A

In vivo drug toxicity studies

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41
Q

Components of Acute Toxicity Studies

A

• Dose Administration
• Observation Period
• Pathology Analysis

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42
Q

During observation period, animals are closely monitored for signs of toxicity, such as changes in ___, ___, and ____.

A

behavior

physiology

mortality

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43
Q

Detailed examination of organ tissues to identify any damage or abnormalities.

A

Pathology Analysis

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44
Q

Components of Sub-chronic Toxicity Studies

A

• Exposure Duration
• Dose Levels
• Comprehensive Evaluation

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45
Q

Exposure Duration : The drug is administered for a longer
period, typically ____, to assess
medium-term effects.

A

28-90 days

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46
Q

In acute toxicity studies, ____ of the drug is given to assess immediate, short-term effects.

A

single, high dose

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47
Q

In sub-chronic toxicity studies, ___ are tested to determine the threshold for toxicity and establish safe dosing ranges.

A

Multiple dose levels

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48
Q

In-depth analysis of clinical chemistry,
hematology, and histopathology to
identify potential organ-specific toxicity.

A

Comprehensive Evaluation

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49
Q

Components of Chronic Toxicity Studies

A

• Long Term Exposure
• Dose Escalation
• Comprehensive Assessment

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50
Q

In chronic toxicity studies, tbe drug is administered for an extended period, typically _____, to assess long-term effects.

A

6 months to 2 years

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51
Q

Gradually increasing the dose over time to identify the maximum tolerable dose and potential cumulative toxicity.

A

Dose Escalation

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52
Q

In-depth evaluation of organ function,
histopathology, and any other adverse
effects that may develop.

A

Comprehensive Assessment

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53
Q

Reproductive Toxicity Studies:

A

• Fertility
• Embryonic/Fetal Development
• Postnatal Development
• Multi-generation Studies

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54
Q

Assessing the drug’s impact on mating, conception, and sperm/egg production.

A

Fertility

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55
Q

Evaluating the drug’s effects on the developing embryo and fetus during pregnancy.

A

Embryonic/Fetal Development

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56
Q

Monitoring the growth and development of offspring exposed to the drug in utero.

A

Postnatal Development

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57
Q

Examining the drug’s effects over multiple generations to identify any heritable changes.

A

Multi-generation Studies

58
Q

Genetic Toxicity Studies

A

• Mutagenicity
• Clastogenicity
• DNA Damage

59
Q

Assessing the drug’s potential to cause permanent changes in the genetic material of cells.

A

Mutagenicity

60
Q

Evaluating the drug’s ability to induce chromosomal breaks, rearrangements, or other abnormalities.

A

Clastogenicity

61
Q

Analyzing the drug’s impact on the integrity and repair of genetic material.

A

DNA Damage

62
Q

Pharmacokinetic Studies

A

• Absorption
• Distribution
• Metabolism
• Excretion

63
Q

Efficacy Studies

A

• Proof-of-Concept
• Dose-Response
• Therapeutic Window
• Long-Term Efficacy

64
Q

Demonstrates the drug’s ability to achieve its intended effect.

A

Proof-of-Concept

65
Q

Determines the optimal dosage for efficacy.

A

Dose-Response

66
Q

Identifies the range of doses that provide benefit without excessive
toxicity.

A

Therapeutic Window

67
Q

Assesses the drug’s effectiveness over extended periods.

A

Long-term Efficacy

68
Q

Safety Pharmacology Studies

A

• Cardiovascular
• Respiratory
• Central Nervous System
• Gastrointestinal

69
Q

Assess effects on heart rate, blood pressure, and rhythm.

A

Cardiovascular

70
Q

Evaluate impact on breathing rate, depth, and lung function.

A

Respiratory

71
Q

Examine effects on behavior, cognition, and motor function.

A

Central Nervous System

72
Q

Assess impact on digestion, absorption, and bowel movements.

A

Gastrointestinal

73
Q

Immunogenicity Studies

A

• Antibody Response
• Cell-Mediated Immunity
• Cytokine Profile
• Histopathology

74
Q

Measure the production of antibodies against the drug or its components.

A

Antibody Response

75
Q

Analyze the levels of various immune signaling molecules (cytokines) in blood or tissues.

A

Cytokine Profile

76
Q

Evaluate the activation of immune cells like T cells, which can directly attack cells
expressing the drug.

A

Cell-Mediated Immunity

77
Q

Examine tissue samples under a microscope to assess the presence of immune cells and inflammation.

A

Histopathology

78
Q

Applying rigorous statistical methods to identify significant drug-related
effects and trends.

A

Statistical Analysis

79
Q

Evaluating how changes in dose affect the magnitude and incidence of observed effects

A

Dose-Response Relationship

80
Q

Carefully translating animal data to predict potential safety and efficacy
in human clinical trials.

A

Extrapolation to Humans

81
Q

The use of animal models in drug development is a complex issue, balancing the need for scientific progress and the ethical treatment of animals.

A
82
Q

Ethical Principles in Animal Research: The 3 Rs

A

• Replacement
• Reduction
• Refinement

83
Q

Seek to replace animal models with alternative methods such as in vitro or in
silico approaches whenever possible.

A

Replacement

84
Q

Design studies to minimize the number of animals used while maintaining scientific validity.

A

Reduction

85
Q

Continually improve procedures to enhance animal welfare and minimize
pain, distress, and suffering.

A

Refinement

86
Q

Ensure that the study design and methodology is robust and can yield meaningful, reproducible results.

A

Scientific Validity

87
Q

Continually seek and implement
alternative methods that can replace
animal models when feasible.

A

Alternative Exploration

88
Q

Carefully weigh the potential benefits
of the research against the risks and
suffering imposed on animals.

A

Minimizing Harm

89
Q

Require rigorous ethical review and
approval before conducting any
animal research studies.

A

Ethical Review

90
Q

Minimizing Animal Suffering:

A

• Anesthesia
• Analgesia
• Euthanasia

91
Q

Utilize appropriate anesthetic agents to eliminate pain and distress during procedures.

A

Anesthesia

92
Q

Provide analgesics to manage pain and discomfort before, during, and after experiments.

A

Analgesia

93
Q

Ensure humane and painless methods of euthanasia when animals must be sacrificed

A

Euthanasia

94
Q

Ensuring Proper Animal Welfare

A

• Housing
• Nutrition
• Veterinary Care

95
Q

Provide appropriate, spacious, and enriched environments to support the
animals’ natural behaviors.

A

Housing

96
Q

Ensure that animals receive a balanced and nutritious diet to maintain their health and well-being.

A

Nutrition

97
Q

Establish comprehensive veterinary oversight to monitor the animals’ health and address any issues promptly.

A

Veterinary Care

98
Q

Limitations of In Vivo Studies

A

• Ethical Considerations
• Species Differences
• High Costs and Time Commitment
• Limited Control Over Variables

99
Q

Animal welfare is paramount,
necessitating strict ethical guidelines
and regulatory oversight to minimize
animal suffering.

A

Ethical Considerations

100
Q

Results from animal models may not
fully translate to humans due to physiological and metabolic variations.

A

Species Differences

101
Q

In vivo studies involve significant
financial investments and time to
conduct, especially for long-term
studies.

A

High Costs and Time Commitment

102
Q

Individual animal responses can vary,
influencing the reliability of study
results and requiring careful statistical
analysis.

A

Limited Control over Variables

103
Q

Balancing Scientific Progress and Ethical
Considerations

A

• Ongoing Dialogue
• Continual Improvement
• Responsible Research

104
Q

Maintain an open and constructive dialogue between researchers, ethicists, and the public.

A

Ongoing Dialogue

105
Q

Continuously strive to enhance
animal welfare and seek alternatives
to reduce reliance on animal
models

A

Continual Improvement

106
Q

Ensure that animal research is
conducted with the highest ethical
standards and scientific rigor.

A

Responsible Research

107
Q

Most common animal used in pre-clinical tests

A

Rodent Models

108
Q

Most common rodent used in the Philippines

A

Mice
Rats

109
Q

A fusion of albino and kitchen rats
- stronger / larger

A

Long-Evans Rats

110
Q

Smaller than Wistar Rats

A

Sprague Dawley Rats

111
Q

Immunomodulation - stimulates the immune system

Immunosuppression - suppression of the immune system

A
112
Q

In Vivo studies assess the potential
for a drug to cause adverse effects,
such as ___,___, and ___.

A

organ damage
reproductive issues
carcinogenicity

113
Q

Long ears, tail length shorter than body length and wider head

A

Wistar Rats

114
Q

Grows faster than Wistar rats (Gain 400 g BW by 12 weeks and Wistar rats gains-350 g BW)

A

Sprague Dawley Rat

115
Q

Black hooded rat. Cross between a female albino and a wild male (Rattus norvegicus)

A

Long-Evans Rat

116
Q

Animal model of essential (or primary) hypertension used to study cardiovascular disease

A

Spontaneous Hypertensive Rats

117
Q

These are a crucial part of the drug development process, allowing researchers to evaluate the potential efficacy and safety of drug candidates before moving to animal and human trials.

A

In vitro drug studies

118
Q

Cell-Based Assays:

A

• Cell Line Selection
• Functional Readouts
• Toxicity Evaluation

119
Q

Choosing the appropriate cell line is
crucial, as it should be representative of
the target tissue or disease state.

A

Cell Line Selection

120
Q

Cell-based assays can measure various
cellular responses, such as proliferation,
differentiation, or signaling pathway
activation.

A

Functional Readout

121
Q

These assays can assess the cytotoxic
effects of drug candidates on cells,
helping identify potential safety concerns.

A

Toxicity Evaluation

122
Q

Genotoxicity and Mutagenicity Tests

A

• Ames Test
• Micronucleus Assay
• Comet Assay

123
Q

Detecting mutagenic potential using bacterial reverse mutation assays.

A

Ames Test

124
Q

Evaluating chromosomal damage and aneuploidy in mammalian cells.

A

Micronucleus Assay

125
Q

Measuring DNA strand breaks and alkaline-labile sites in individual cells.

A

Comet Assay

126
Q

Receptor Binding Assays

A

• Receptor Specificity
• Binding Affinity
• Functional Activation

127
Q

These assays determine the selectivity of a drug candidate for its intended receptor target, versus off-target receptors.

A

Receptor Specificity

128
Q

Receptor binding assays quantify the strength of the interaction between a drug candidate and its target receptor.

A

Binding Affinity

129
Q

They quantify the strength of the interaction between a drug candidate and its target receptor.

A

Receptor binding assays

130
Q

Some receptor binding assays also measure the ability of a drug candidate to activate or inhibit the receptor’s downstream signaling pathways.

A

Functional Activation

131
Q

Biochemical/Enzyme Activity Assays

A

• Enzyme Inhibition
• Enzyme Kinetics
• High-Throughput Screening

132
Q

These assays determine the ability of a drug candidate to inhibit the activity of a target enzyme, which can be a potential
mechanism of action.

A

Enzyme Inhibition

133
Q

Enzyme activity assays can provide information on the kinetic parameters of an enzyme-drug interaction, such as the rate of catalysis or inhibition.

A

Enzyme Kinetics

134
Q

Enzyme activity assays are well-suited for high-throughput screening of
large chemical libraries to identify potential drug candidates.

A

High-Throughput Screening

135
Q

Permeability Studies

A

• Passive Diffusion
• Active Transport
• Blood-Brain Barrier

136
Q

Measures the ability of a drug candidate to passively diffuse across cell membranes, which is crucial for oral bioavailability.

A

Passive Diffusion

137
Q

Evaluates the potential for a drug candidate to be a substrate or
inhibitor of membrane transporter proteins.

A

Active Transprt

138
Q

Assesses the likelihood of a drug candidate to cross the blood-
brain barrier and reach the central nervous system

A

Blood-Brain Barrier

139
Q

Metabolic Stability Studies

A

• Metabolism Pathways
• Metabolite Profiling

140
Q

These studies identify the major
metabolic pathways and enzymes
involved in the biotransformation of a
drug candidate.

A

Metabolism Pathways

141
Q

Metabolic stability assays can provide a
comprehensive understanding of the
drug’s metabolic fate and potential
metabolite-mediated effects.

A

Metabolite Profiling

DDD (9 decks)

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