Safety Pharmacology MCQ

1. What does the therapeu- It measures the margin of safety between theratic index (TI) measure in peutic and toxic dose of a drug. relation to toxicity? 2. What is the differNOAEL ( no observed adverse effect level) is ence between NOAEL the highest dose without any observed adverse and LOAEL in toxicology effects studies? LOAEL - lowest dose with adverse effects 3. What is a surrogate bio- predict toxicity of a substance in humans marker used for in toxicology studies? 4. What is the primary Covalent bonding mechanism of mutagenic chemicals when they interact with DNA? 5. What are cholinesterase improving memory and cognitive function inhibitors commonly used for in medical treatment? 6. What is the specific car- TdP (torsades de pointes) diac syndrome associated with the drug terfenadine that can be life-threatening? 7. What is the gold standard - the most reliable and accurate method available in the context of drug for comparison testing? 8. What is a surrogate bio- an indictator used as a substitute for a biological marker? endpoint to predict clinical benefit/harm It can help predict how a patient may respond to a drug without directly measuring the clinical endpoint 1/5 9. What is hepatotoxicity? toxicity to the liver due to reactive metabolites reactive metabolites can cause damage to the liver, leading to hepatoxicity 10. What is idiosyncratic na- Effects that vary among individuals due to genetic ture? traits these effects can be challenging to predict / detect because they differ from person to person based on their genetic makeup 11. What are Biosteres? substitutents / functional groups that have chemical/ physical similarities and produce similiar biological properties they can be used in drug design to modify compounds while enhancing their desired effects 12. What is LOAEL? min conc of a substance needed to elicit a toxic effect 13. What is the primary antioxidant? Glutathione (protects from oxidative stress) 14. What does TdP risk stand risk of are lethal heart condition for? this risk is associated with certain medications that can lead to a specific type of irregular heart rhythm that can be life-threatening 15. What is safety pharmacology? regulatory-driven process to generate data that informs risk/benefit assessment, predicting whether a drug is likely to be found unsafe to prevent such an occurrence. 16. stimulate mammalian metabolism 2/5 Why is rat liver extract - this addition helps mimic how the substance added during the in vitro would be metabolised in a mammalian system, Ames test? providing more relvant results regarding potential mutagenicity. 17. What is NOAEL in the max dose of a compound that a laboratory anidose-response relation- mal/ human receive without showing any observship? able toxicity/adverse effects It helps to determine if there is a dose-threshold limit that must be exceeded for toxicity to be observed 18. How does cytochrome alteting substance metabolism P450 impact NOAEL in the dose-response rela- their activity can lead to the production of more tionship? toxic metabolites than the original compound, potentially causing adverse effects and reducing the safety margin between therapeutic and toxic doses 19. What is glutathione de- reduction in the levels of glutathione, which is the pletion and its role in the primary antioxidant in the body. body? It plays a crucial role in protecting cells from oxidative stress and maintaining overall cellular health. 20. What are the main target The liver and kidney are commonly observed as organs for a toxic drug, target organs for toxic drugs because they are and why is toxicity to involved in drug metabolism and excretion. the liver and kidney commonly observed? 21. How are the liver and kid- - the liver plays a key role in metabolising drugs, ney crucial in processing breaking them down into forms that can be easily and removing drugs from excreted and their byproducts through urine the body? 22. Safety pharmacology: 3/5 - it is a regulatory driven process - It involves P.D and P.K characterisation - It includes preclinical testing - It includes requirements to predict rare lethal effects 23. why was the antihistit required several million prescriptions to be isamine terfenadine with- sued before an adverse event was identified drawn from the market? 24. What does safety pharmacology focuses on: focusing on assessing and predicting the potential risks and adverse effects of drugs 25. How does S.P evolve? S.P adapts and improves with the advancement of scientific methods and technologies. 26. Why does S.P evolve? To better assess the safety profile of new chemical entities. 27. Are all drug toxiciwhile some drug toxicites can be caused by reacties caused by reactive tive metabolites, not all drug toxicites are solely metabolites of the parent attributed to reactive mtabolites. compound? 28. Type ADR A vs Type ADR - Type ADR are typically predictable, dose-depenB: dent, and related to the pharmacological action of the drug. They are often reversible upon discontinuation of the drug / dose adjustment. - Type A reactions are more common and tend to be less severe compared to type B reactions - which are unpredictable, dose-dependent, and can be more serious / irreversible with nature 29. Changes to the dose rela- pharmacological effects tionship are more related to the 30. Type B adverse drug re- are usually unpredictable idiosyncratic reactions actions initiated by a reactive metabolite 4/5 31. Reactive metabolites can cause toxicity via 1 of several non covalent processes: - depletion of glutathione - modification of sulfhyryl groups - formation of reactive O2 species - lipid peroxidation 32. Can a drug elicit its pharmacological/toxicological action via more than 1 mechanism of action? A drug can elicit pharmacological / toxicological action through more than 1 mechanism of action. 33. What does ED50 measure? measure potency / effectivenss of a drug Many drugs have multiple targets / pathways in the body, leading to various effects. 34. What does the presence there may be a protective mechanism in place of NOEL suggest? that prevents adverse effects at that particular dose. 35. The addition of liver ex- In the ames test, the addition of liver extracts is tracts prevents false pos- not to prevent false positive / negative results but itive / negative bacteria: rather stimulate the metabolic activation of certain compounds in the body, which can lead to the formation of mutagenic metabolites. Liver extracts are used to mimic the metabolic processes that can occur in vivo. 36. What is false-positive? saying something that is positive but is negative 37. What is false negative? something negative but is positive this is more dangerous Example: missing a condition that requires treatment, leading to delay in necessary care and potentially allowing the condition to worsen. 5/5