Here are some possible viva questions and answers related to adverse drug effects:
- What are adverse drug effects (ADEs)?
- Adverse drug effects are undesirable or harmful responses to medications taken at therapeutic doses. These effects can be related to the drug’s pharmacological action or occur as a result of the drug’s toxic properties.
- Differentiate between adverse drug reactions and side effects.
- Adverse drug reactions (ADRs) are any noxious, unintended, and undesired effects of a drug, while side effects are expected, known, and often mild effects of a drug that are not the primary therapeutic outcome.
- What are the different types of adverse drug reactions?
- There are several types of ADRs, including:
- Type A (Augmented): Dose-dependent and predictable reactions, often due to the drug’s pharmacological action.
- Type B (Bizarre): Idiosyncratic and unpredictable reactions not related to the drug’s pharmacological action.
- Type C (Chronic): Reactions that occur with prolonged drug use.
- Type D (Delayed): Reactions that manifest long after drug administration.
- Type E (End of use): Reactions that occur upon drug discontinuation.
- There are several types of ADRs, including:
- What is the difference between an allergic reaction and a non-allergic adverse drug reaction?
- Allergic reactions involve the immune system’s response to a drug and can manifest as hives, itching, or anaphylaxis. Non-allergic reactions are typically dose-related or idiosyncratic and do not involve the immune system.
- How are adverse drug reactions classified by severity?
- Adverse drug reactions can be classified as mild, moderate, or severe, depending on their impact on the patient. Severity is often determined by factors such as the need for medical intervention, hospitalization, or life-threatening potential.
- Explain the concept of dose-response relationship in adverse drug effects.
- The dose-response relationship in adverse drug effects refers to the relationship between the dose of a drug and the likelihood and severity of adverse effects. Some ADRs are directly related to the drug’s dosage, with higher doses increasing the risk of adverse effects.
- What is the Beers Criteria, and why is it important in the context of adverse drug effects?
- The Beers Criteria is a list of potentially inappropriate medications for older adults. It is important because older adults are more susceptible to adverse drug effects due to age-related changes in metabolism and physiology. The criteria help healthcare providers make safer medication choices for this population.
- How can healthcare professionals minimize the risk of adverse drug effects?
- Healthcare professionals can reduce the risk of ADEs by carefully assessing a patient’s medical history, allergies, and current medications, prescribing the lowest effective dose, monitoring for signs of ADEs, and providing patient education on drug usage and potential side effects.
- What is pharmacovigilance, and how does it contribute to the understanding of adverse drug effects?
- Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It helps identify and report ADRs, contributing to a better understanding of drug safety.
- Give an example of a common adverse drug effect and its management.
- Example: Gastrointestinal upset (e.g., nausea, vomiting) from non-steroidal anti-inflammatory drugs (NSAIDs).
- Management: Consider dose reduction, take with food, or switch to a different pain reliever if the symptoms persist.
These questions and answers cover various aspects of adverse drug effects and can serve as a starting point for your viva preparation in this topic. Be sure to expand on your answers with relevant examples and current research findings if necessary.
Viva questions about the severity of adverse drug reactions (ADRs) can help assess your understanding of how ADRs are classified based on their impact on patients. Here are some potential viva questions and answers on this topic:
- What is the importance of assessing the severity of adverse drug reactions?
- The severity assessment of ADRs is crucial because it helps healthcare professionals prioritize patient safety, make informed treatment decisions, and determine the appropriate interventions and management strategies.
- How are adverse drug reactions classified by severity?
- Adverse drug reactions can be classified into three main categories based on severity:
- Mild: ADRs that are usually tolerable, do not require specific treatment, and have minimal impact on the patient’s daily life.
- Moderate: ADRs that may cause discomfort, require medical intervention, and potentially affect the patient’s ability to perform daily activities.
- Severe: ADRs that are life-threatening, require urgent medical attention, and significantly impair the patient’s ability to function.
- Adverse drug reactions can be classified into three main categories based on severity:
- Give examples of mild, moderate, and severe adverse drug reactions.
- Mild: Mild gastrointestinal upset (e.g., nausea, diarrhea) from antibiotics.
- Moderate: Skin rash or hives due to an allergic reaction to a medication.
- Severe: Anaphylaxis or severe liver toxicity resulting from drug use.
- Explain the factors that can influence the severity of adverse drug reactions.
- The severity of ADRs can be influenced by factors such as the patient’s age, overall health, the dose and duration of drug exposure, individual variations in drug metabolism, and the presence of underlying medical conditions.
- How is the severity of adverse drug reactions assessed in clinical practice?
- Severity assessment often involves clinical evaluation, laboratory tests, and the use of standardized severity scales. Common scales include the Common Terminology Criteria for Adverse Events (CTCAE) and the Hartwig Severity Assessment Scale.
- What are the potential consequences of not recognizing or underestimating the severity of adverse drug reactions?
- Underestimating the severity of ADRs can lead to delayed or inadequate treatment, potentially causing harm to the patient, and in severe cases, it can result in life-threatening outcomes.
- Discuss the role of pharmacovigilance in assessing the severity of adverse drug reactions.
- Pharmacovigilance plays a vital role in the collection and evaluation of ADR reports from healthcare professionals and patients. The severity of ADRs is assessed within pharmacovigilance systems to identify patterns and trends and take appropriate regulatory actions when necessary.
- How can healthcare professionals manage severe adverse drug reactions?
- Management of severe ADRs involves immediate discontinuation of the causative medication, supportive care, administration of specific antidotes if available, and addressing the patient’s symptoms and complications.
- What strategies can healthcare providers employ to prevent or reduce the severity of adverse drug reactions?
- Strategies include careful patient assessment, personalized drug selection, monitoring for early signs of ADRs, and patient education. Additionally, healthcare providers can consider adjusting drug dosages, using therapeutic drug monitoring, and employing alternative medications when appropriate.
- Give an example of a situation where the severity of an adverse drug reaction could be underestimated and the potential consequences.
- Example: Underestimating the severity of a skin rash as a side effect of a new medication.
- Potential consequences: Delay in recognizing that the rash is a sign of a serious allergic reaction, leading to continued medication use, worsening of the reaction, and potential life-threatening consequences.
These questions and answers cover various aspects of the severity of adverse drug reactions and can help you prepare for a viva examination in this area. Be sure to provide examples and real-life scenarios to illustrate your points and demonstrate a deeper understanding of the topic.
Viva questions related to the prevention of adverse effects to drugs are important in the field of pharmacology and healthcare to assess your knowledge of strategies and practices aimed at reducing the risk of adverse drug effects. Here are some potential viva questions and answers on this topic:
- Why is it essential to prevent adverse effects of drugs?
- Preventing adverse drug effects is crucial to ensure patient safety, improve treatment outcomes, and minimize healthcare costs associated with treating complications.
- What are the key principles in preventing adverse drug effects?
- The key principles include personalized medicine, appropriate drug selection, dosage optimization, monitoring, and patient education.
- Explain the concept of personalized medicine in the prevention of adverse drug effects.
- Personalized medicine involves tailoring drug therapy to an individual’s genetic, biochemical, and clinical characteristics. It aims to maximize drug efficacy while minimizing the risk of adverse effects based on the patient’s unique profile.
- How can healthcare professionals select drugs to prevent adverse effects?
- Drug selection should consider a patient’s medical history, allergies, concomitant medications, and potential drug interactions. Choosing drugs with a favorable benefit-risk profile is essential.
- Discuss the role of drug dosage optimization in preventing adverse effects.
- Dosage optimization involves selecting the appropriate dose for a patient based on factors like age, weight, organ function, and pharmacogenetic variations. It aims to achieve therapeutic effects while minimizing toxicity.
- What are the best practices for monitoring patients to prevent adverse drug effects?
- Regular patient monitoring includes assessing vital signs, laboratory parameters, and clinical symptoms. It helps identify early signs of adverse effects, allowing for timely intervention.
- How can patient education contribute to the prevention of adverse drug effects?
- Patient education involves informing patients about their medications, potential side effects, and the importance of adhering to the prescribed regimen. Informed patients are more likely to recognize and report adverse effects promptly.
- Discuss the role of medication reconciliation in preventing adverse drug effects.
- Medication reconciliation is the process of creating an accurate list of a patient’s current medications and comparing it to the current medication orders. This helps identify discrepancies and potential drug-related issues.
- What are some common drug-drug interactions, and how can they be prevented?
- Common drug-drug interactions include potentiation, antagonism, and interference with drug metabolism. To prevent them, healthcare providers should be aware of potential interactions and adjust medication regimens accordingly.
- Give an example of a situation where the prevention of adverse drug effects can be challenging and how it can be addressed.
- Example: Preventing adverse effects in a patient with multiple comorbidities and complex medication regimens.
- Addressing it: Simplify the medication regimen, conduct a comprehensive medication review, and involve a clinical pharmacist to optimize the drug therapy.
- Explain the role of therapeutic drug monitoring in preventing adverse drug effects.
- Therapeutic drug monitoring (TDM) involves measuring drug concentrations in a patient’s blood to ensure they are within the therapeutic range. TDM helps prevent toxicity and optimize drug effectiveness.
- How can healthcare systems and policies contribute to the prevention of adverse drug effects?
- Healthcare systems can implement medication safety initiatives, develop guidelines, and promote interprofessional collaboration to improve the prevention of adverse drug effects on a broader scale.
These questions and answers cover various aspects of preventing adverse drug effects and can assist you in preparing for a viva examination on this topic. Providing practical examples and real-world scenarios can enhance your responses and demonstrate a comprehensive understanding of the subject.
Viva questions related to the side effects of drugs are important in the field of pharmacology and medicine to assess your understanding of the various aspects of drug side effects. Here are some potential viva questions and answers on this topic:
- What is a drug side effect, and how does it differ from the drug’s intended therapeutic effect?
- A drug side effect, also known as an adverse effect, is an unintended and often undesirable response to a medication. It differs from the drug’s therapeutic effect, which is the intended and beneficial outcome of the treatment.
- Can you categorize drug side effects?
- Yes, drug side effects can be categorized into several types, including common side effects, serious side effects, idiosyncratic reactions, and allergic reactions.
- Explain the difference between common side effects and serious side effects of drugs.
- Common side effects are mild and often expected reactions to a drug. Serious side effects are severe and may require immediate medical attention.
- What are idiosyncratic reactions in the context of drug side effects?
- Idiosyncratic reactions are unpredictable and rare side effects that are not related to the drug’s known pharmacological properties. They can occur in a subset of the population and are often genetically determined.
- How do you recognize and manage common side effects of drugs?
- Common side effects are often recognized through patient reporting and clinical monitoring. Management may involve dose adjustment, symptomatic treatment, or continued observation, depending on the specific side effect.
- Give examples of common side effects associated with specific drug classes.
- Common side effect of non-steroidal anti-inflammatory drugs (NSAIDs): Gastrointestinal irritation, including stomach pain and indigestion.
- Common side effect of certain antibiotics: Diarrhea.
- What is the role of informed consent in managing drug side effects?
- Informed consent is essential in medical practice to ensure patients are aware of potential side effects and agree to the treatment plan. It allows patients to make educated decisions about their healthcare.
- Discuss the difference between side effects, adverse drug reactions, and allergic reactions to drugs.
- Side effects encompass all unintended effects of a drug, whether they are mild or severe. Adverse drug reactions (ADRs) refer to undesirable effects that are harmful and often require medical attention. Allergic reactions are a subset of ADRs involving an immune response to the drug.
- What factors can influence the likelihood and severity of drug side effects in patients?
- Factors include patient characteristics (age, genetics, overall health), drug properties (dose, route of administration), and drug interactions with other medications or substances.
- Explain the concept of a dose-response relationship in the context of drug side effects.
- A dose-response relationship refers to the correlation between the drug dose and the likelihood and severity of side effects. Some side effects are more likely to occur or be more severe at higher doses.
- What is the significance of post-marketing surveillance in detecting and monitoring drug side effects?
- Post-marketing surveillance helps identify and monitor side effects that may not have been evident in clinical trials. It is crucial for patient safety and may lead to regulatory actions or updated safety information.
- Give an example of a situation where the occurrence of a drug side effect may necessitate the discontinuation of the drug.
- Example: Severe liver toxicity caused by a medication.
- Necessity for discontinuation: To prevent further harm to the patient’s liver, and it may be life-threatening if the medication is continued.
These questions and answers cover various aspects of drug side effects and can help you prepare for a viva examination on this topic. Be sure to provide specific examples and real-life scenarios to illustrate your points and demonstrate a deeper understanding of the subject.
Viva questions related to drug intolerance, idiosyncrasy, and drug allergy are essential in the field of pharmacology and medicine to assess your knowledge of various adverse drug reactions. Here are some potential viva questions and answers on these topics:
- What is drug intolerance, and how does it differ from other adverse drug reactions?
- Drug intolerance is the reduced ability of an individual to tolerate a drug, resulting in unpleasant symptoms. It is different from other adverse drug reactions in that it is usually dose-dependent and not immune-mediated.
- Give examples of drug intolerance reactions.
- Examples of drug intolerance reactions include gastrointestinal upset, such as nausea and vomiting, caused by some medications.
- How can drug intolerance be managed or prevented?
- Drug intolerance can often be managed by reducing the drug dosage, taking the medication with food, or using alternative formulations. Prevention involves careful patient assessment and drug selection.
- What is drug idiosyncrasy, and how does it differ from predictable drug reactions?
- Drug idiosyncrasy refers to uncommon and unpredictable reactions to a drug that are not related to its known pharmacological actions. This is in contrast to predictable drug reactions, which are related to the drug’s known effects.
- Can you provide examples of idiosyncratic reactions to drugs?
- Examples of idiosyncratic reactions include severe cutaneous adverse reactions (SCARs) like Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Explain the genetic factors that can contribute to idiosyncratic drug reactions.
- Genetic factors can influence drug metabolism, enzyme activity, and immune responses, making some individuals more susceptible to idiosyncratic reactions. For example, variations in genes encoding drug-metabolizing enzymes can affect drug disposition.
- Define drug allergy and its immunological basis.
- Drug allergy is an immune-mediated adverse drug reaction involving an allergic response to a medication. It typically involves the production of specific antibodies, such as IgE, and immune cells that target the drug.
- What are the common manifestations of drug allergies?
- Common manifestations include skin rashes, itching, hives, swelling, respiratory symptoms, and, in severe cases, anaphylaxis.
- How can healthcare providers diagnose drug allergies?
- Diagnosis of drug allergies often involves a detailed patient history, physical examination, skin testing, blood tests (e.g., specific IgE), and, in some cases, drug provocation tests under medical supervision.
- Explain the importance of avoiding drugs to which a patient has a known drug allergy.
- Avoiding drugs to which a patient has a known drug allergy is critical because re-exposure can lead to a more severe and potentially life-threatening allergic reaction. Identifying and documenting allergies is vital for patient safety.
- Provide examples of commonly allergenic drugs.
- Commonly allergenic drugs include penicillin and other beta-lactam antibiotics, sulfa drugs, and nonsteroidal anti-inflammatory drugs (NSAIDs).
- How can healthcare professionals manage drug allergies in patients who require a medication to which they are allergic?
- Management may involve identifying alternative medications, desensitization protocols, and close monitoring in a controlled medical setting, depending on the clinical situation and available options.
These questions and answers cover the concepts of drug intolerance, idiosyncrasy, and drug allergy. Be prepared to expand on your answers with specific examples, clinical scenarios, and the latest research findings to demonstrate a comprehensive understanding of these adverse drug reactions during your viva examination.
Viva questions related to the mechanisms and types of allergic reactions are important in the field of immunology, pharmacology, and medicine. Here are some potential viva questions and answers on these topics:
Mechanisms of Allergic Reactions:
- Explain the basic mechanism of allergic reactions.
- Allergic reactions occur when the immune system recognizes a harmless substance (allergen) as a threat and triggers an immune response. This response involves the production of immunoglobulin E (IgE) antibodies and the release of inflammatory mediators, such as histamine, leading to allergy symptoms.
- Describe the role of mast cells in allergic reactions.
- Mast cells play a central role in allergic reactions. When activated by IgE antibodies binding to allergens, mast cells release histamine and other mediators, causing the characteristic allergy symptoms.
- What is the difference between an immediate hypersensitivity reaction and a delayed hypersensitivity reaction?
- Immediate hypersensitivity reactions, also known as type I hypersensitivity, occur within minutes of allergen exposure and involve IgE-mediated responses. Delayed hypersensitivity reactions (type IV) typically take 48 hours or more to develop and involve T-cell responses.
Types of Allergic Reactions:
- Discuss the four main types of hypersensitivity reactions and provide examples.
- The four types are:
- Type I: Immediate hypersensitivity (e.g., anaphylaxis, allergic rhinitis).
- Type II: Antibody-mediated hypersensitivity (e.g., hemolytic transfusion reactions).
- Type III: Immune complex-mediated hypersensitivity (e.g., serum sickness).
- Type IV: Delayed-type hypersensitivity (e.g., contact dermatitis).
- The four types are:
- Explain the characteristics and mechanisms of a type I hypersensitivity reaction.
- Type I hypersensitivity is characterized by IgE-mediated mast cell degranulation. When allergen-specific IgE antibodies bind to allergens, mast cells release histamine and other mediators, causing immediate symptoms such as hives, swelling, and anaphylaxis.
- Describe the mechanisms involved in a type II hypersensitivity reaction.
- Type II hypersensitivity reactions involve antibodies targeting specific antigens on cell surfaces. For example, in autoimmune hemolytic anemia, antibodies attack red blood cells, leading to their destruction.
- What is the immune complex-mediated mechanism in type III hypersensitivity?
- In type III hypersensitivity, immune complexes form when antibodies and antigens bind together in circulation. These complexes can deposit in tissues, leading to inflammation and tissue damage, as seen in conditions like systemic lupus erythematosus (SLE).
- Discuss the role of T cells in type IV hypersensitivity reactions.
- In type IV hypersensitivity, T cells play a central role. These reactions are mediated by T lymphocytes, which become sensitized to an antigen and release cytokines, leading to inflammation. An example is contact dermatitis.
- Provide an example of a clinical condition that represents each type of hypersensitivity reaction.
- Type I: Allergic asthma (immediate hypersensitivity).
- Type II: Autoimmune hemolytic anemia (antibody-mediated).
- Type III: Rheumatoid arthritis (immune complex-mediated).
- Type IV: Contact dermatitis (delayed-type).
- How can allergies be diagnosed and managed effectively?
- Allergies can be diagnosed through a combination of patient history, skin testing, blood tests (e.g., specific IgE levels), and challenge tests. Management includes allergen avoidance, pharmacotherapy (antihistamines, corticosteroids), and, in some cases, allergen immunotherapy (desensitization).
These questions and answers provide an overview of the mechanisms and types of allergic reactions. Be prepared to delve into specific examples, clinical manifestations, and current research in your viva examination to demonstrate a comprehensive understanding of allergic responses and their clinical relevance.
Viva questions on the treatment of drug allergies are important for assessing your knowledge of how to manage allergic reactions to medications. Here are some potential viva questions and answers on this topic:
- What is the first step in the treatment of a suspected drug allergy reaction?
- The first step is to discontinue the suspected medication immediately to prevent further exposure to the allergen.
- How can the management of a drug allergy reaction differ based on its severity?
- The management of drug allergy reactions can range from discontinuation of the drug and symptomatic treatment for mild reactions to more aggressive interventions, such as epinephrine for severe anaphylactic reactions.
- Explain the use of antihistamines in the treatment of drug allergy reactions.
- Antihistamines are commonly used to alleviate the symptoms of mild allergic reactions. They work by blocking the effects of histamine, a key mediator of allergy symptoms like itching, hives, and runny nose.
- When is the administration of corticosteroids appropriate in the management of drug allergies?
- Corticosteroids are typically used in moderate to severe drug allergy reactions to reduce inflammation and suppress the immune response. They are not typically used for immediate relief but may be prescribed in the aftermath of a reaction.
- What is the role of epinephrine in treating severe drug allergy reactions?
- Epinephrine is a life-saving medication used to counteract the severe symptoms of anaphylaxis, a potentially life-threatening allergic reaction. It works by constricting blood vessels, relaxing airway muscles, and reducing systemic allergic response.
- Discuss the importance of having an anaphylaxis action plan for patients with known drug allergies.
- An anaphylaxis action plan outlines steps to be taken in case of an allergic reaction, including the administration of epinephrine. It is crucial for patients with known drug allergies, as prompt treatment can save lives.
- What is the role of desensitization in managing drug allergies, and when is it considered?
- Desensitization involves administering gradually increasing doses of a medication to reduce the risk of an allergic reaction. It is considered when there are no suitable alternatives to a necessary drug, and the benefits outweigh the risks.
- Explain the concept of cross-reactivity in drug allergies.
- Cross-reactivity occurs when an individual is allergic to one drug and subsequently reacts to a structurally similar drug due to shared allergenic properties. This is common in drug classes like penicillins.
- What measures should be taken to avoid future exposure to the offending drug in patients with known drug allergies?
- Patients should wear a medical alert bracelet, carry an epinephrine auto-injector, and inform healthcare providers and pharmacists about their allergy. Additionally, it is essential to thoroughly review medication labels and inquire about drug ingredients.
- Can you explain the role of allergen immunotherapy in managing drug allergies?
- Allergen immunotherapy is used for environmental allergies and is not generally employed in the treatment of drug allergies. It involves exposing the patient to increasing amounts of the allergen to build tolerance over time.
- How can healthcare professionals help prevent drug allergies in the clinical setting?
- Healthcare professionals can help prevent drug allergies by conducting thorough patient assessments, obtaining detailed drug histories, and ensuring accurate patient information in medical records to avoid known allergens.
These questions and answers cover various aspects of the treatment of drug allergies. Be prepared to provide examples and discuss specific drug allergy scenarios during your viva examination to demonstrate a comprehensive understanding of this important topic.
Viva questions related to teratogenicity, carcinogenicity, and mutagenicity are crucial for evaluating your understanding of the potential risks associated with drugs and chemicals. Here are some viva questions and answers on these topics:
- Define teratogenicity and teratogens.
- Teratogenicity refers to the ability of a substance to cause birth defects or malformations in a developing fetus. Teratogens are substances, including drugs or chemicals, that can induce these abnormalities during pregnancy.
- Explain the critical periods during pregnancy when teratogenic effects are most likely to occur.
- The critical periods are the embryonic period (weeks 3-8) when organogenesis occurs and the fetal period (after week 8) when growth and maturation continue. Teratogenic effects can vary depending on the timing of exposure.
- What are some examples of well-known teratogenic agents and the birth defects they can cause?
- Thalidomide: Limb defects.
- Warfarin: Central nervous system and skeletal abnormalities.
- Accutane (Isotretinoin): Craniofacial, cardiovascular, and neural tube defects.
- How can teratogenicity be prevented or minimized during pregnancy?
- Teratogenicity can be minimized by avoiding potentially harmful substances, conducting thorough risk assessments, ensuring effective contraception when using teratogenic drugs, and educating healthcare professionals and pregnant women about potential risks.
- Define carcinogenicity and carcinogens.
- Carcinogenicity refers to the ability of a substance to cause cancer. Carcinogens are agents or substances that can induce or promote the development of cancer.
- Explain the differences between genotoxic and non-genotoxic carcinogens.
- Genotoxic carcinogens cause DNA damage, mutations, or chromosomal abnormalities, which are the primary factors leading to cancer. Non-genotoxic carcinogens promote cancer through other mechanisms, such as cell proliferation.
- Provide examples of well-established carcinogens and the types of cancer they are associated with.
- Tobacco smoke: Lung, throat, and bladder cancer.
- Asbestos: Lung cancer and mesothelioma.
- Benzene: Leukemia.
- What are the challenges and ethical considerations when conducting studies to determine the carcinogenicity of a substance in humans?
- Challenges include long latency periods for cancer development, ethical concerns regarding exposing humans to potential carcinogens, and the need for large and long-term studies. Many carcinogenicity assessments are based on animal studies and in vitro experiments.
- Define mutagenicity and mutagens.
- Mutagenicity is the ability of a substance to cause genetic mutations. Mutagens are agents or substances that induce changes in an organism’s DNA.
- Explain the significance of mutagenicity in relation to cancer development.
- Mutagenic substances can lead to DNA mutations, which are a key step in the process of cancer initiation. These mutations can disrupt normal cellular functions and lead to uncontrolled cell growth.
- What tests and assays are commonly used to evaluate the mutagenic potential of substances?
- Common tests include the Ames test, in vitro mammalian cell mutation assays, and the in vivo micronucleus assay. These assays help assess the genotoxic potential of chemicals and drugs.
- Discuss the regulatory aspects and safety measures in place to address the potential mutagenicity of pharmaceuticals and chemicals.
- Regulatory agencies such as the FDA and EMA require thorough mutagenicity assessments during the drug development process. If a substance is found to be mutagenic, regulatory actions may include restricted use or labeling requirements.
These questions and answers cover various aspects of teratogenicity, carcinogenicity, and mutagenicity. Be prepared to provide examples and discuss specific substances and their effects during your viva examination to demonstrate a comprehensive understanding of these concepts.