Fundamentals of Toxicology
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What type of toxicology study is conducted during the clinical development phase?

  • Acute toxicology studies lasting 1-4 weeks
  • Reprotoxicology studies focusing on reproduction
  • In vitro toxicology studies such as AMES
  • Chronic toxicology studies lasting 3-6 months (correct)

Which of the following substances can potentially be toxic based on the information provided?

  • Natural sugars
  • Essential oils
  • Household chemicals (correct)
  • Motor oil (correct)

During what phase of drug development are acute toxicology studies primarily conducted?

  • Pre-clinical development (correct)
  • Post-marketing surveillance
  • Discovery phase
  • Clinical development

What does Paracelsus's statement imply about toxins?

<p>All substances can be toxic if the dose is high enough. (D)</p> Signup and view all the answers

Which study assesses the potential for a substance to cause cancer?

<p>Carcinogenicity studies (C)</p> Signup and view all the answers

What type of toxicity is characterized by predictable effects related to the pharmacological action of a drug?

<p>Type A - Augmented (A)</p> Signup and view all the answers

Which type of toxicity is specifically linked to cumulative effects after prolonged usage of a medication?

<p>Type C - Chronic (C)</p> Signup and view all the answers

What is the primary focus of pharmacovigilance?

<p>To detect and prevent adverse effects (B)</p> Signup and view all the answers

An unexpected adverse event is defined as one that is inconsistent with what?

<p>Approved labeling or documents (C)</p> Signup and view all the answers

What kind of toxic effects can appear upon discontinuation of a drug?

<p>Type E - End of use (B)</p> Signup and view all the answers

Which of the following examples illustrate Type B toxicity?

<p>Hypersensitivity reactions (B)</p> Signup and view all the answers

Cumulative toxicity is most likely associated with which type of medication usage?

<p>Regular prolonged use (A)</p> Signup and view all the answers

What is one of the responsibilities associated with pharmacovigilance?

<p>To report adverse events (A)</p> Signup and view all the answers

What is the potential consequence of a dog ingesting chocolate?

<p>CNS dysfunction and renal failure (B)</p> Signup and view all the answers

Which of the following is a common source of poisoning in dogs?

<p>Xylitol (A)</p> Signup and view all the answers

When should emetics be used after poisoning?

<p>Within 2-3 hours of ingestion (D)</p> Signup and view all the answers

Which medication is NOT a dopamine agonist used to induce vomiting in dogs?

<p>Activated charcoal (A)</p> Signup and view all the answers

What should be avoided when inducing vomiting in case of poisoning?

<p>If there is severe CNS depression (C)</p> Signup and view all the answers

What is the most effective timing for administering activated charcoal?

<p>Within 1 hour of ingestion (A)</p> Signup and view all the answers

What is the potential outcome of a dog consuming grapes or raisins?

<p>Renal failure (A)</p> Signup and view all the answers

Which condition is NOT typically associated with antifreeze poisoning?

<p>Severe diarrhea (D)</p> Signup and view all the answers

What is defined as the dose that will kill 50% of the test population?

<p>LD50 (A)</p> Signup and view all the answers

Which of the following best describes a serious adverse event?

<p>An adverse event resulting in death or life-threatening conditions (A)</p> Signup and view all the answers

What differentiates acute toxicity from chronic toxicity?

<p>Acute toxicity arises from short-term exposure (C)</p> Signup and view all the answers

In what situation can toxicity occur during normal use of medicines?

<p>When higher than recommended dosages are taken (D)</p> Signup and view all the answers

Which of the following is NOT considered an adverse event?

<p>A favorable outcome following medication use (B)</p> Signup and view all the answers

What is a common result of chronic toxicity?

<p>Cumulative toxic effects over time (C)</p> Signup and view all the answers

An adverse event can occur after which types of medicine usage?

<p>Both off-label and on-label uses (D)</p> Signup and view all the answers

Which term is used to describe diseases that occur at the same time as a serious adverse reaction?

<p>Concurrent diseases (B)</p> Signup and view all the answers

What does LD50 represent in toxicology?

<p>The dose that kills 50% of a test population (B)</p> Signup and view all the answers

Which statement accurately defines a serious adverse event?

<p>A reaction that results in death or is life-threatening (C)</p> Signup and view all the answers

Which type of toxicity results from a single or short-term exposure to a substance?

<p>Acute toxicity (D)</p> Signup and view all the answers

What distinguishes chronic toxicity from acute toxicity?

<p>Chronic toxicity arises from long-term exposure (A)</p> Signup and view all the answers

Adverse Drug Reactions (ADRs) can occur during which of the following situations?

<p>During normal use of medicines (D)</p> Signup and view all the answers

Which of the following is NOT a reason why toxicity might occur during normal medication use?

<p>Comprehensive safety reports (D)</p> Signup and view all the answers

Which approach should be taken when dealing with a suspected adverse event?

<p>Make an official report (B)</p> Signup and view all the answers

What is the primary role of regulators concerning 'Adverse Event' definitions?

<p>To standardize safety assessment and pharmacovigilance (C)</p> Signup and view all the answers

Flashcards

LD50

The dose of a substance that causes death in 50% of a test population.

Adverse Drug Reaction (ADR) / Adverse Drug Event (ADE)

Any harmful or undesirable response to a drug, regardless of the dose.

Serious Adverse Event (SAE)

An adverse event that results in death, is life-threatening, causes significant disability or incapacity, or leads to birth defects.

Acute Toxicity

Toxicity that occurs due to a single dose or multiple doses given within a short period of time (typically 14 days).

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Chronic Toxicity

Toxicity that develops over time due to prolonged exposure to a substance. Effects accumulate over time.

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Toxicology

The study of the harmful effects of substances on living organisms. It involves understanding how substances interact with cells, tissues, and organs to cause adverse effects.

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Acute Toxicology Studies

Acute toxicology studies focus on the immediate effects of a substance, often at high doses, over a short timeframe (1-4 weeks). They help determine the potential for acute toxicity, like a rapid reaction.

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Chronic Toxicology Studies

Chronic toxicology studies evaluate the long-term effects of a substance at lower doses over a longer period (3-6 months). They assess the potential for cumulative effects and chronic diseases.

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Reprotoxicology Studies

Reprotoxicology studies investigate the effects of a substance on reproduction, including fertility, pregnancy, and development of offspring. They help ensure substances don't harm future generations.

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Carcinogenicity Studies

Carcinogenicity studies examine the potential of a substance to cause cancer. These studies are long-term, lasting up to 2 years, and use low doses to mimic typical human exposure.

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Xylitol

A sugar alcohol often found in sugar-free gum and candy, potentially causing hypoglycemia in dogs.

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Atypical Myopathy (Equine)

A condition affecting horses, caused by ingesting sycamore tree leaves or seeds, leading to muscle weakness and paralysis.

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Antifreeze (Ethylene Glycol)

A substance commonly found in antifreeze, toxic to animals, causing kidney failure, tremors and neurological issues.

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Medicines

A type of medication that can be toxic to animals, causing various problems like liver or kidney failure.

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Emetics

A method used to induce vomiting after poisoning ingestion, effective only if administered quickly and safely.

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Activated Charcoal

A charcoal-based product used to absorb toxins in the stomach, effective if administered within an hour of ingestion.

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Gastric Lavage

A procedure involving flushing the stomach with a solution to remove ingested toxins.

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Veterinary Poisons Information Service

A website dedicated to providing information about poisoning in pets, offering resources and support for owners.

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Adverse Event

Any observation in animals, unfavorable and unintended, after using a veterinary medicinal product (VMP), regardless of whether it's related to the product.

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Serious Adverse Event

Any adverse event that results in death, life-threatening situations, permanent disability, congenital anomalies, or birth defects.

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Toxicity during Normal Use

Toxicity that can happen during the normal use of medicines, accidental ingestions, environmental exposure, or drug development.

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SAR Report Details

Information required for a Suspected Adverse Reaction (SAR) report.

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SAR Report Content

Details required in a SAR report: Who, What, When, Where, and How.

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What are Type E toxic effects?

Toxic effects that occur when the drug is stopped or discontinued. These effects are not caused by the primary action of the drug but rather by the body's response to the removal of the drug.

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What are Type C toxic effects?

Toxicity that develops over time after prolonged use of a drug. This is due to the cumulative effects of the drug in the body.

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What are Type B toxic effects?

Adverse reactions that are unrelated to the primary pharmacological action of the drug. These reactions are often unpredictable and can vary widely between individuals. They are caused by the body's immune system reacting to the drug, not the drug itself.

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What are Type A toxic effects?

Toxic effects that are expected and directly related to the primary pharmacological action of the drug. These effects are usually dose-dependent, meaning they become more severe with higher doses.

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What is pharmacovigilance?

The practice of collecting, analyzing, and evaluating information on the safety of drugs after they have been released to the market. It involves identifying, assessing, and preventing adverse drug reactions.

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What makes an adverse event unexpected?

An adverse event is considered unexpected when its nature, severity, or outcome is not consistent with the approved labeling or documentation of the drug.

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What is an SAR report?

A report used to formally document a suspected adverse event related to a medicine. It includes information about the reporter, the patient, the drug, and the event itself.

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Why can toxicity occur during the normal use of medicines?

Toxicity that occurs during the 'normal' use of medicines, meaning the drug is being used as prescribed and at the recommended dose. It can be classified into different types based on the underlying mechanism of toxicity.

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Study Notes

Fundamentals of Toxicology

  • All substances are poisons; the right dose differentiates a poison from a remedy - Paracelsus (1493-1541)

Learning Outcomes

  • Define lethal dose, adverse event, and serious adverse reaction
  • Differentiate acute from chronic toxicity
  • Describe situations where toxicity may occur (e.g., during medicine development, adverse events, poisoning)
  • Explain why toxicity might occur during normal medicine use
  • Describe how to deal with a suspected adverse event and make an official report

Pre-read - Key points

  • Lethal dose (LD50): The dose that kills 50% of a test population.
  • Adverse Drug Reaction/Event: Any harmful or undesirable response to a drug.
    • Adverse events are any observations in animals, whether or not considered to be product related, that are unfavorable and unintended and that occur after any use of a Veterinary Medicinal Product (VMP) – off-label and on-label uses.
    • A serious adverse event is any adverse event which results in death, is life-threatening, results in persistent or significant disability/incapacity, or a congenital anomaly or birth defect.
  • Acute toxicity: Results from a single dose or multiple doses in a short time period (usually within 14 days).
  • Chronic toxicity: Develops from long-term exposure. Toxic effects are cumulative.

Novel Drug Development

  • Discovery phase: in vitro toxicology studies (e.g., Ames).
  • Pre-clinical development: Acute toxicology studies (1-4 weeks, high dose), reprotoxicology studies.
  • Clinical development: Chronic toxicology studies (3-6 months, low-intermediate dose); carcinogenicity studies (2 years, low dose).

Sources of Toxins

  • Plants
  • Animals
  • Fungi
  • Inorganic material
  • Drugs and medicines
  • Pesticides
  • Household chemicals
  • Industrial chemicals

Common Sources of Poison

  • Xylitol (hypoglycemia)
  • Grapes and raisins (renal failure)
  • Chocolate (CNS/renal failure/arrhythmias)
  • Sycamore (atypical myopathy)
  • Rat poison (hemorrhage)
  • Mycotoxins (convulsions/coma)
  • Antifreeze (ataxia/tremors/PU/PD)
  • Medicines (renal/liver failure, adder bites, etc.)

Theobromine in Chocolate

  • 200g chocolate bar: ~1g theobromine
    • Dogs at risk: All
  • Dairy milk: ~400mg theobromine
    • Dogs at risk: ≤ 20kg, but err on side of caution
  • Milkybar: ~2mg theobromine
    • Dogs at risk: None

Veterinary Poisons Information Service

Emetics

  • Used primarily to induce vomiting after poisoning.
  • Only useful if initiated within 2-3 hours of ingestion.
  • Do not induce vomiting if the poison is corrosive, causes severe CNS depression, seizures, reduced gag reflex, or bradycardia.
  • Examples: apomorphine, ropinirole, xylazine, hydrogen peroxide 3%

Decontamination

  • Activated charcoal: Adsorbant, most effective within 1 hour of ingestion. Only adsorbs toxins in the liquid phase.
  • Gastric lavage: A method of decontamination.

Toxicity During Normal Medicine Use

  • Type A: Augmented - Predictable, related to the pharmacological action (e.g., bleeding with anticoagulants). Dose-dependent, more common.
  • Type B: Bizarre - Unrelated to the pharmacological action (e.g., hypersensitivity reaction).
  • Type C: Chronic - Cumulative toxicity after prolonged use.
  • Type D: Delayed - Teratogenic or carcinogenic effects.
  • Type E: End of use - Toxic effects appear when the drug is stopped.

Hypersensitivity Reactions

  • Type I: Allergic anaphylaxis and atopy
  • Type II: Antibody
  • Type III: Immune complex
  • Type IV: Delayed

Reporting Adverse Events

  • Necessary information: identified reporter, details of the affected animal or human, the product concerned, details of the suspected adverse reaction.

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Related Documents

Fundamentals of Toxicology Lecture Slides PDF

Description

Explore the key principles of toxicology, including the definitions of lethal dose, adverse events, and serious adverse reactions. Understand the distinctions between acute and chronic toxicity, and learn about the circumstances surrounding toxicity during medicine use and development. This quiz will help you grasp essential concepts necessary for addressing and reporting adverse events.

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