Non-clinical evaluation and safety testing MCQs With Answer

Non-clinical evaluation and safety testing are essential preclinical steps that assess a drug’s toxicity, pharmacokinetics, and biological effects before human trials. For B. Pharm students, understanding study types—acute, subchronic, chronic, genotoxicity, carcinogenicity, reproductive toxicity, safety pharmacology—and guidelines such as GLP, OECD and ICH is vital. Learn about endpoints like LD50, NOAEL, MTD, ADME profiling, in vitro assays (Ames, cytotoxicity), in vivo animal models, dose selection, and regulatory reporting. This knowledge builds the foundation for designing, interpreting, and justifying safety studies and prepares you for research and regulatory roles. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of non-clinical safety testing in drug development?

• To determine commercial pricing of a drug
• To evaluate safety and toxicological profile before human trials
• To assess patient adherence in clinical trials
• To replace clinical trials entirely

Correct Answer: To evaluate safety and toxicological profile before human trials

Q2. Which guideline series primarily covers non-clinical safety evaluation for pharmaceuticals?

• ICH S series
• EMA Q series
• FDA G series
• ICH M series

Correct Answer: ICH S series

Q3. NOAEL stands for which of the following?

• Normal Observed Adverse Effect Limit
• Non-Observed Adverse Effect Level
• No Observable Adverse Effect Level
• Nominal Observable Acute Effect Level

Correct Answer: No Observable Adverse Effect Level

Q4. Which assay is commonly used to assess mutagenicity in non-clinical testing?

• ELISA
• Ames test
• Western blot
• HPLC

Correct Answer: Ames test

Q5. LD50 relates to which concept in toxicity testing?

• Dose producing a beneficial effect in 50% of animals
• Lowest dose with observable adverse effects
• Dose lethal to 50% of the test population
• Maximum tolerated dose over 50 days

Correct Answer: Dose lethal to 50% of the test population

Q6. Which study assesses effects on reproduction and development across generations?

• Acute toxicity study
• Reproductive and developmental toxicity study
• Mutagenicity battery
• Safety pharmacology single-dose study

Correct Answer: Reproductive and developmental toxicity study

Q7. GLP stands for which regulatory concept important for non-clinical studies?

• Good Laboratory Practice
• General Lab Procedure
• Good Licensing Protocol
• Guideline for Lab Performance

Correct Answer: Good Laboratory Practice

Q8. Which endpoint is most relevant to safety pharmacology focused on cardiovascular risk?

• Bone marrow suppression
• QT interval prolongation and hERG channel effects
• Hepatic enzyme induction
• Renal clearance rate

Correct Answer: QT interval prolongation and hERG channel effects

Q9. The maximum tolerated dose (MTD) is defined as:

• The lowest dose that shows therapeutic effect in animals
• The dose that causes minimal but acceptable toxicity
• The dose lethal to all animals tested
• The highest dose with absolutely no adverse effects

Correct Answer: The dose that causes minimal but acceptable toxicity

Q10. Which regulatory documents provide test methods for chemical safety in animals?

• ICH guidelines
• OECD Test Guidelines
• USP monographs
• EMA marketing authorizations

Correct Answer: OECD Test Guidelines

Q11. In ADME studies, ‘A’ stands for:

• Allocation
• Absorption
• Activation
• Adaption

Correct Answer: Absorption

Q12. Which in vitro model is often used to study metabolic stability of drugs?

• Primary hepatocytes or liver microsomes
• Neuronal cell lines
• Bone marrow cultures
• Renal epithelial monolayer only

Correct Answer: Primary hepatocytes or liver microsomes

Q13. A battery of genotoxicity tests typically includes all EXCEPT:

• Ames test
• In vitro mammalian chromosomal aberration test
• In vivo micronucleus test
• Chronic inhalation carcinogenicity study

Correct Answer: Chronic inhalation carcinogenicity study

Q14. Which animal species is commonly used for chronic toxicity studies for small molecules?

• Fish
• Beagle dogs and rodents (rats or mice)
• Non-mammalian insects
• Reptiles

Correct Answer: Beagle dogs and rodents (rats or mice)

Q15. Carcinogenicity testing is primarily designed to detect:

• Immediate allergic reactions
• Potential of a substance to induce tumors over long term
• Short-term liver enzyme inhibition
• Drug-drug interactions

Correct Answer: Potential of a substance to induce tumors over long term

Q16. Which parameter is crucial when selecting dose levels for toxicity studies?

• Color of the compound
• Pharmacodynamic receptor occupancy only
• Exposure margins, MTD, and relevance to human exposure
• Manufacturer’s preferred dose

Correct Answer: Exposure margins, MTD, and relevance to human exposure

Q17. Immunotoxicity studies assess:

• Effects on cardiac conduction
• Potential adverse effects on immune system function
• Gastrointestinal motility only
• Genomic sequence changes

Correct Answer: Potential adverse effects on immune system function

Q18. Which term describes the study of local tissue reaction at the site of administration?

• Systemic toxicity
• Local tolerance
• Carcinogenicity
• Pharmacodynamics

Correct Answer: Local tolerance

Q19. Which ICH guideline addresses reproductive toxicity testing?

• ICH S2
• ICH M3(R2)
• ICH S5
• ICH Q8

Correct Answer: ICH S5

Q20. For biotechnology-derived products, which non-clinical consideration is especially important?

• Protein immunogenicity and cross-reactivity
• Color stability in tablets
• pH-dependent release in vitro only
• Microbial dissolution rate

Correct Answer: Protein immunogenicity and cross-reactivity

Q21. Which study is required to support first-in-human single ascending dose clinical trials?

• Short-term toxicity studies in two species and safety pharmacology
• Full lifetime carcinogenicity in rodents
• Multi-generational reproductive study
• Market surveillance data

Correct Answer: Short-term toxicity studies in two species and safety pharmacology

Q22. Bioanalytical method validation in non-clinical studies ensures:

• That analytical instruments are trademarked
• Accuracy, precision, sensitivity and specificity of assays
• Animal welfare compliance only
• That study reports are written in a specific font

Correct Answer: Accuracy, precision, sensitivity and specificity of assays

Q23. Which organ system is a primary focus of safety pharmacology per ICH S7A?

• Cardiovascular, central nervous system, and respiratory systems
• Exocrine pancreas only
• Integumentary system only
• Hair follicle cyclicity

Correct Answer: Cardiovascular, central nervous system, and respiratory systems

Q24. In vitro cytotoxicity testing primarily helps to:

• Measure compound color change
• Identify potential cell-killing effects and guide in vivo testing
• Replace regulatory toxicology requirements entirely
• Assess human clinical efficacy directly

Correct Answer: Identify potential cell-killing effects and guide in vivo testing

Q25. Which metric is commonly used to compare safety margins between animal and human exposure?

• Cmax or AUC-based safety margin (exposure margin)
• Tablet hardness score
• IC50 in unrelated assay
• Solubility only

Correct Answer: Cmax or AUC-based safety margin (exposure margin)

Q26. The in vivo micronucleus test detects:

• Protein folding abnormalities
• Chromosomal damage or loss in bone marrow cells
• Changes in blood glucose only
• Enzyme induction in liver microsomes

Correct Answer: Chromosomal damage or loss in bone marrow cells

Q27. Which concept is central to the 3Rs in animal testing ethics?

• Respect, Review, Record
• Reduce, Refine, Replace
• Rehabilitate, Rehouse, Reuse
• Randomize, Replicate, Report

Correct Answer: Reduce, Refine, Replace

Q28. Which parameter indicates hepatic injury in toxicology studies?

• Elevated ALT and AST enzymes
• Reduced bone density
• Lowered intraocular pressure
• Increased hair growth

Correct Answer: Elevated ALT and AST enzymes

Q29. A bridging study in non-clinical testing is used to:

• Assess consumer preference between brands
• Compare new formulation or species differences to existing data
• Determine final manufacturing cost
• Replace GLP requirements

Correct Answer: Compare new formulation or species differences to existing data

Q30. Which factor is NOT typically part of a regulatory toxicology study report?

• Study design, methods, and results
• Statistical analysis and raw data tables
• Principal investigator signature and GLP statement
• Marketing strategy and pricing plan

Correct Answer: Marketing strategy and pricing plan

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