IN VIVO TESTING Flashcards
Involves experiments conducted on living organisms, typically animals, to observe effects of a drug in a whole-body system.
IN VIVO TESTING
Involves experiments performed in isolated cells, tissues, or organs outside of a living organisms, providing a simplified model for studying drug effects.
IN VITRO TESTING
Evaluating the safety of drugs through _____ studies is a critical step in drug development process. These studies use live animal models to assess the potential risks and side effects of a drug candidate before clinical trials in humans.
IN VIVO
In vivo studies provide valuable insights into how a drug interacts with a living organism, including its?
ABSORPTION, DISTRIBUTION, METABOLISM and EXCRETION
In vivo studies provide ______ into how a drug interacts with a living organisms, including its absorption, distribution, metabolism and excretion.
VALUABLE INSIGHTS
In vivo study provide valuable insights into how a drug interacts with a living organisms, including its absorption, distribution, metabolism and excretion.
UNDERSTANDING DRUG BEHAVIOR
These studies assess the potential for a drug to cause adverse effects, such as organ damage, reproductive issues, or carcinogenicity.
EVALUATING TOXICITY
The data from in vivo studies helps researchers design safer and more effective clinical trials in human participants.
INFORMING CLINICAL TRIALS
Drug safety evaluations must comply with guidelines set by organizations like the?
FDA - FOOD AND DRUGS ADMINISTRATION
EMA - EUROPEAN MEDICINES AGENCY
OECD- ORGANIZATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
Drug safety evaluations must comply with guidelines set by organizations like the FDA, EMA, OECD.
GLOBAL REGULATORY BODIES
In vivo studies must adhere to strict animal welfare regulations and protocols to minimize suffering.
ETHICAL CONSIDERATIONS
Regulatory agencies provide standardized study designs and methods to ensure consistent, high-quality data.
STANDARDIZED PROTOCOLS
The primary agency responsible for regulating animal use in drug development in the Philippines is the _____ which is under the Department of Agriculture (DA).
BUREAU OF ANIMAL INDUSTRY (BAI)
The primary agency responsible for regulating animal use in drug development in the Philippines is the Bureau of Animal Industry which is under the ______?
DEPARTMENT OF AGRICULTURE (DA)
The BAI oversees and implements the ______, which provides the legal framework for the humane treatment if animals used in research and development.
ANIMAL WELFARE ACT OF 1998 (REPUBLIC ACT NO. 8485)
4 roles of Bureau of Animal Industry (BAI)
• ISSUE PERMITS
• MONITOR AND INSPECT
• INVESTIGATE COMPLAINTS
• PROMOTE ETHICAL PRACTICES
Involved in setting standards for the use of animals in biomedical research.
DEPARTMENT OF HEALTH (DOH)
The DOH may be Involved in setting standards for the use of animals in ______.
BIOMEDICAL RESEARCH
May provide guidelines and ethical review for research involving animals.
PHILIPPINE COUNCIL FOR HEALTH RESEARCH AND DEVELOPMENT (PCHRD)
Are established with research institutions to review and approve animal use protocols.
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEES (IACUCs)
Who is the head of Institutional Animal Care and Use Committees (IACUCs)
VETERINARIAN
what is REC
RESEARCH ETHICS COMMITTEE
This department is established in university.
INSTITUTIONAL ANIMAL CARE AND USE COMMITEEs (IACUCS)
2 types if Animal Models for Drug Testing:
RODENT MODELS
NON-RODENT MODELS
3 Rodent Models:
MICE
RATS
GUINEA PIGS
2 Rodent Models that is usually used in the Philippines
MICE
RATS
Most Common Animal Models for Drug Testing?
RODENT MODELS
Small size, short lifespan, east to breed and handle.
MICE
Larger size, longer lifespan, more robust physiology.
RATS
Rodent Model most common in US
GUINEA PIGS
A rodent model that is Similar to human in terms of vitamin C requirements
GUINEA PIGS
4 Non-Rodent Models:
PRIMATES
PIGS
DOGS
RABBITS
A non-rodent model that is closest to humans in terms of physiology and genetics, valuable for studying diseases like HIV and Alzheimer’s.
PRIMATES
A non-rodent model that test in monkey
PRIMATES
Used for studying organ transplantation and cardiovascular research, similar size and anatomy to humans.
PIGS
A non-rodent model that is large animal models for studying cancer; diabetes and cardiovascular diseases, long lifespan allows for chronic studies.
5/10 year study
DOGS
A non-rodent model used for studying reproductive and developmental toxicology convenient size and relatively low cost.
RABBITS
They are widely used in drug research due to their physiological similarities to humans.
RATS
What do you call an albino rats?
WISTAR RATS
A rat that is easier to die and weak?
WISTAR RATS
Are an albino strain characterized by their white fur and pink eyes
WISTAR RATS
They are known for their rapid growth adaptability, making them suitable for various research purposes.
WISTAR RATS
Wistar Rats are commonly used in?
• TOXICOLOGY
• CANCER RESEARCH
• BEHAVIORAL STUDIES
They predictable responses to drug treatments make them valuable models for evaluating drug efficacy and safety.
WISTAR RATS
They are smaller than Wistar Rats.
SPRAGUE DAWLEY RATS
are a popular strain known for their docile nature, rapid growth rate, a d high reproductive rate.
SPRAGUE DAWLEY RATS
Sprague Dawley Rats are commonly used in the study of?
• TOXICOLOGY
• PHARMACOLOGY
• SAFETY TESTING
Their consistent physiology allows for reliable data collection and interpretation.
SPRAGUE DAWLEY RATS
Researchers often used ____ rats for general toxicity testing and to evaluate drug efficacy.
SPRAGUE DAWLEY RATS
A fusion of albino and kitchen rats.
LONG-EVANS RATS
Are known for their hooded coat pattern, featuring a darker, pigmented area on the head and shoulders.
LONG-EVANS RATS
They are often used in behavioral research due to their well-documented behavioral pattern and responses.
LONG-EVANS RATS
They are valuable models for studying neurological disorders and drug-induced behavioral changes.
LONG-EVANS RATS
Long ears, tail lengths shorter than body lengths and wider head
WISTAR RATS
Grows faster than Wistar Rats, (Gain 400 g BW by 12 weeks and Wistar rats gain- 350 g BW)
SPRAGUE DAWLEY RATS
Black hooded rat. Cross between a female albino and a wild male (Rattus norvegicus)
LONG-EVANS RATS
Are genetically predisposed to hypertension, characterized by elevated blood pressure.
SPONTANEOUSLY HYPERTENSIVE RATS (SHR)
These rats are commonly used in research on cardiovascular disease, including stroke, heart failure and hypertension.
SPONTANEOUSLY HYPERTENSIVE RATS (SHR)
Animal model of essential (or primary) hypertension used to study cardiovascular disease.
SPONTANEOUSLY HYPERTENSIVE RATS
They are valuable models for evaluating new drugs for hypertension and other cardiovascular disorders.
SPONTANEOUSLY HYPERTENSIVE RATS
Their sensitivity to hypertension makes them particularly useful for testing the efficacy or antihypertensive drugs.
SPONTANEOUSLY HYPERTENSIVE RATS
Are genetically predisposed to obesity and type 2 diabetes.
ZUCKER DIABETIC FATTY RATS
Zucker Diabetic Fatty Rats are genetically presdisposed to _____ and _____.
OBESITY and Type 2 Diabetes
These rats are characterized by their distinctive white fur and tendency to develop insulin resistance.
ZUCKER DIABETIC FATTY RATS
Are valuable models for studying diabetes, obesity and related metabolic disorders.
ZUCKER DIABETIC FATTY RATS
Researchers utilize ____ to evaluate the efficacy and safety of new drugs for managing diabetes and obesity.
ZUCKER DIABETES FATTY RATS
Consider the specific genetic makeup of the rat strain, as it can influence susceptibility to diseases and drug responses.
GENETIC BACKGROUND
Ensure that rats are healthy and free from pre-existing conditions that might confused research findings.
HEALTH STATUS
Controlled environmental conditions, including temperature, humidity, and light cycles, are crucial for consistent results.
ENVIRONMENTAL FACTORS
A SINGLE, HIGH DOSE OF THE DRUG IS GIVEN TO ASSESS IMMEDIATE SHORT-TERM EFFECTS.
Acute Toxicity Studies:
DOSE ADMINISTRATION
OBSERVATION PERIOD
PATHOLOGY ANALYSIS
The drug is administered for a longer period, typically ____, to assess medium-term effects.
28-90 DAYS
Multiple dose levels are tested to determine the threshold for toxicity and establish safe dosing ranges.
DOSE LEVELS
The drug is administered for an extended period, typically ____ to assess long-term effects.
6 months - 2 years
3 Sub chronic Toxicity Studies:
EXPOSURE DURATION
DOSE LEVELS
COMPREHENSIVE EVALUATION
3 Chronic Toxicity Studies:
LONG-TERM EXPOSURE
DOSE ESCALATION
COMPREHENSIVE ASSESSMENET
The drug is administered for a longer period, typically 28-90 days, to assess medium-term effects.
EXPOSURE DURATION
In-depth analysis of clinical chemistry, hematology, and histopathology to identify potential organ-specific toxicity.
COMPREHENSIVE EVALUATION
The drug is administered for an extended period, typically 6 months to 2 years, to assess long-term effects.
LONG-TERM EXPOSURE
Gradually increasing the dose over time to identify the maximum tolerable dose and potential cumulative toxicity.
DOSE ESCALATION
In-depth evaluation of organ function, histopathology, and any other adverse effects that may develop.
COMPREHENSIVE ASSESSMENT
Assessing the drug’s impact on mating, conception and sperm/egg production.
FERTILITY
Fertility is assessing the drug’s impact on?
MATING, CONCEPTION and SPERM/EGG PRODUCTION
Evaluating the drug’s effects on the developing embryo and fetus during pregnancy.
EMBRYONIC/FETAL DEVELOPMENT
Monitoring the growth and development of offspring exposed to the drug in utero.
POSTNATAL DEVELOPMENT
Examining the drug’s effects over multiple generations to identify any heritable changes.
MULTI-GENERATION STUDIES
4 Reproductive Toxicity Studies:
FERTILITY
EMBRYONIC/FETAL DEVELOPMENT
POSTNATAL DEVOPMENT
MULTI-GENERATION STUDIES
Assessing the drug’s potential to cause permanent changes in the genetic material of cells.
MUTAGENICITY
Evaluating the drug’s ability to induce chromosomal breaks, rearrangements, or other abnormalities.
CLASTOGENICITY
Analyzing the drug’s impact on the integrity and repair of genetic material
DNA DAMAGE
Demonstrates the drug’s ability to achieve its intended effect.
PROOF-OF-CONCEPT
Determines the optimal dosage for efficacy.
DOSE RESPONSE
Identifies the range of doses that provide benefit without excessive toxicity.
THERAPEUTIC WINDOW
Assesses the drug’s effectiveness over extended period.
LONG-TERM EFFICACY
Assess effects on heart rate, blood pressure and rhythm.
CARDIOVASCULAR
Cardiovascular assess effects on ____, ____, ____?
HEART RATE
BLOOD PRESSURE
RHYTHM
Evaluate impact on breathing rate, depth, and lung function.
RESPIRATORY
Examines effects on behavior cognition, and motor function.
CENTRAL NERVOUS SYSTEM
Assess impact on digestion, absorption, and bowel movement.
GASTROINTESTINAL
Gastrointestinal assess impact on ____, _____, _____?
DIGESTION
ABSORPTION
BOWEL MOVEMENTS
Respiratory evaluate impact on ____, ____, _____?
BREATHING RATE
DEPTH
LUNG FUNCTION
Central Nervous System examine effects on ____, ____, _____?
BEHAVIOR
COGNITIVE
MOTOR FUNCTION
It increase immune system
IMMUNODULATION
It decrease immune system
IMMUNOSUPRESSION
Measure the production of antibodies against the drug or its components.
ANTIBODY RESPONSE
Examines tissue samples under a microscope to access the presence of immune cells and inflammation.
HISTOPATHOLOGY
3R’d in Ethical Principles in Animal Research:
REPLACEMENT
REDUCTION
REFINEMENT
Seek to replace animal models with alternative methods such as in vitro or in silico approaches whenever possible.
REPLACEMENT
Design studies to minimize the number of animals used while maintaining scientific validity.
REDUCTION
Continually improve procedures to enhance animal welfare and minimize pain, distress, and suffering.
REFINEMENT
Injection is better than ____, delivers directly into GIT.
GAVAGE
It is better than GAVAGE, delivers directly into GIT.
INJECTION
Utilize appropriate anesthetic agents to eliminate pain and distress during procedures.
ANESTHESIA
Provide analgesics to manage pain and discomfort before, during, and after experiments.
ANALGESIA
Ensure humane and painless methods of euthanasia when animals must be sacrificed.
EUTHANASIA
Provide appropriate, spacious, and enriched environments to support animal’s natural behaviors.
HOUSING
Ensure that animals receive a balanced and nutritious diet to maintain their health and well-being.
NUTRITION
Establish comprehensive veterinary oversight to monitor the animals’ health and address any issues promptly.
VETERINARY CARE
