Preclinical evaluation phase MCQs with answers provide B.Pharm students a focused review of nonclinical drug assessment including toxicology, pharmacokinetics (PK), pharmacodynamics (PD), ADME, safety pharmacology and regulatory requirements. This collection emphasizes animal studies, in vitro assays, GLP compliance, NOAEL/LD50 determination, genotoxicity, carcinogenicity, reproductive toxicity, and toxicokinetics to build practical understanding for drug safety evaluation. Questions target study design, OECD and ICH guidelines, dose selection, biomarkers, histopathology, and data interpretation to bridge theory and lab practice. These MCQs help strengthen exam preparation, critical thinking and regulatory awareness essential for preclinical research careers. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of the preclinical evaluation phase?
- To assess drug safety and biological activity before human trials
- To market the drug directly to consumers
- To conduct phase IV post-marketing surveillance
- To replace clinical trials entirely
Correct Answer: To assess drug safety and biological activity before human trials
Q2. Which of the following components is central to preclinical evaluation?
- Pharmacokinetics, pharmacodynamics, and toxicology
- Market analysis and sales forecasting
- Phase III clinical endpoints
- Hospital formulary management
Correct Answer: Pharmacokinetics, pharmacodynamics, and toxicology
Q3. Good Laboratory Practice (GLP) in preclinical studies primarily ensures what?
- Integrity, reproducibility and traceability of nonclinical data
- Faster approval by marketing agencies
- Lower cost of animal maintenance
- Guaranteed clinical efficacy in humans
Correct Answer: Integrity, reproducibility and traceability of nonclinical data
Q4. Which ICH guideline specifically addresses nonclinical safety studies for human clinical trials?
- ICH M3(R2)
- ICH Q1A(R2)
- ICH E6(R2)
- ICH Q3A
Correct Answer: ICH M3(R2)
Q5. LD50 in acute toxicity testing denotes what?
- The dose that causes death in 50% of the test animals
- The lowest dose with therapeutic effect in animals
- The safest effective human dose
- The dose that produces no observable adverse effect
Correct Answer: The dose that causes death in 50% of the test animals
Q6. NOAEL stands for which of the following?
- No Observed Adverse Effect Level
- New Observed Active Enzyme Level
- Normal Ocular Assessment Evaluation Limit
- Non-Observable Analytical Error Limit
Correct Answer: No Observed Adverse Effect Level
Q7. Maximum Tolerated Dose (MTD) is defined as:
- The highest dose producing acceptable toxicity but not death
- The minimum effective dose in humans
- The dose that cures disease in animals
- The dose without any pharmacological effect
Correct Answer: The highest dose producing acceptable toxicity but not death
Q8. Which in vitro test is commonly used to detect bacterial mutagenicity?
- Ames test using Salmonella strains
- MTT cell viability assay
- Western blot for protein expression
- ELISA for cytokine levels
Correct Answer: Ames test using Salmonella strains
Q9. Carcinogenicity studies in rodents are primarily used to evaluate:
- Long-term cancer risk associated with chronic exposure
- Acute allergic reactions after a single dose
- Immediate cardiovascular safety
- Microbial contamination of formulations
Correct Answer: Long-term cancer risk associated with chronic exposure
Q10. In reproductive toxicity testing, “Segment II” traditionally refers to:
- Embryo-fetal development study
- Fertility and early embryonic development
- Peri-natal and postnatal development
- Carcinogenicity assessment
Correct Answer: Embryo-fetal development study
Q11. The safety pharmacology core battery typically includes which organ systems?
- Cardiovascular, respiratory and central nervous systems
- Renal, hepatic and endocrine systems
- Gastrointestinal, musculoskeletal and immune systems
- Dermatologic, ophthalmic and dental systems
Correct Answer: Cardiovascular, respiratory and central nervous systems
Q12. What is the role of liver microsomal stability assays in preclinical ADME?
- Assess metabolic clearance mediated by hepatic enzymes
- Measure renal excretion rates directly
- Determine tissue distribution in brain
- Detect genotoxic impurities
Correct Answer: Assess metabolic clearance mediated by hepatic enzymes
Q13. Allometric scaling is used to:
- Predict human pharmacokinetic parameters from animal data
- Standardize laboratory animal diets
- Measure drug stability under heat
- Estimate tablet dissolution rates
Correct Answer: Predict human pharmacokinetic parameters from animal data
Q14. Toxicokinetics differs from pharmacokinetics mainly because:
- It measures systemic exposure within toxicity studies to correlate with adverse effects
- It only studies absorption in healthy volunteers
- It excludes clearance and distribution parameters
- It focuses solely on therapeutic efficacy
Correct Answer: It measures systemic exposure within toxicity studies to correlate with adverse effects
Q15. The Maximum Recommended Starting Dose (MRSD) for first-in-human trials is commonly derived from:
- Animal NOAEL with appropriate safety/factor scaling
- Average human therapeutic dose from literature
- Highest tested animal dose regardless of toxicity
- In vitro IC50 values only
Correct Answer: Animal NOAEL with appropriate safety/factor scaling
Q16. In vitro–in vivo correlation (IVIVC) is important because it:
- Links in vitro dissolution to in vivo absorption and bioavailability
- Measures animal lifespan after dosing
- Assesses color uniformity of formulations
- Predicts microbial contamination risk
Correct Answer: Links in vitro dissolution to in vivo absorption and bioavailability
Q17. Histopathology in preclinical toxicology is used primarily to:
- Identify microscopic tissue changes and target organ toxicity
- Measure blood drug concentration
- Analyze chemical structure of the drug
- Determine clinical trial recruitment numbers
Correct Answer: Identify microscopic tissue changes and target organ toxicity
Q18. OECD guidelines in toxicology provide:
- Standardized protocols for safety testing accepted internationally
- Marketing strategies for pharmaceutical products
- Clinical trial endpoints for phase III studies
- Dietary recommendations for laboratory animals
Correct Answer: Standardized protocols for safety testing accepted internationally
Q19. Absolute oral bioavailability (F) is calculated by comparing which parameters?
- AUC after oral dosing versus AUC after IV dosing adjusted for dose
- Time to peak concentration only
- Half-life in two different species
- LD50 values across species
Correct Answer: AUC after oral dosing versus AUC after IV dosing adjusted for dose
Q20. Which body typically reviews and approves animal experiments in India?
- Institutional Animal Ethics Committee (IAEC)
- Data Safety Monitoring Board (DSMB)
- Central Drugs Standard Control Organization (CDSCO) directly
- Institutional Review Board (IRB) for humans
Correct Answer: Institutional Animal Ethics Committee (IAEC)
Q21. A commonly used in vitro cytotoxicity assay for cell viability is:
- MTT assay
- Ames bacterial reverse mutation
- In vivo micronucleus test
- Western blot assay
Correct Answer: MTT assay
Q22. The Ames test primarily detects which type of genetic damage?
- Mutagenicity (point mutations or frameshifts) in bacteria
- Chromosomal aberrations in humans
- Protein misfolding in vitro
- Mitochondrial DNA deletions
Correct Answer: Mutagenicity (point mutations or frameshifts) in bacteria
Q23. Which in vivo test is commonly used to detect chromosomal damage in mammals?
- Micronucleus test
- MTT assay
- HPLC impurity profiling
- Dissolution testing
Correct Answer: Micronucleus test
Q24. Which endpoint is most informative for identifying organ-specific toxicity?
- Histopathological examination of organs
- Solubility testing of the compound
- In vitro protein binding only
- Label claim review
Correct Answer: Histopathological examination of organs
Q25. Toxicokinetic sampling in toxicity studies is used to:
- Correlate systemic exposure (AUC, Cmax) with observed toxic effects
- Calculate marketing prices
- Assess tablet hardness
- Measure patient adherence
Correct Answer: Correlate systemic exposure (AUC, Cmax) with observed toxic effects
Q26. Liver microsome studies primarily evaluate which metabolic pathway?
- Cytochrome P450-mediated metabolism
- Renal tubular secretion
- Gastric acid hydrolysis
- Dermal absorption kinetics
Correct Answer: Cytochrome P450-mediated metabolism
Q27. Which preclinical study is essential to assess embryo‑fetal development risk?
- Segment II (embryo-fetal development) study
- Acute dermal toxicity study
- Subchronic inhalation irritation test
- In vitro receptor binding only
Correct Answer: Segment II (embryo-fetal development) study
Q28. A fundamental requirement of GLP is:
- Comprehensive documentation and traceability of study data
- Publication of all study results regardless of relevance
- Use of human volunteers for all tests
- Immediate regulatory approval without review
Correct Answer: Comprehensive documentation and traceability of study data
Q29. Which pharmacokinetic parameter primarily indicates the rate of drug absorption?
- Tmax (time to reach Cmax)
- AUC (area under the curve)
- Clearance
- Volume of distribution
Correct Answer: Tmax (time to reach Cmax)
Q30. For medicines intended for chronic lifelong use, which additional nonclinical study is typically required?
- Carcinogenicity studies in rodents
- Single-dose dermal irritation only
- Short-term microbiology screening
- Taste masking evaluation
Correct Answer: Carcinogenicity studies in rodents

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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