Preclinical drug evaluation parameters MCQs With Answer

Preclinical drug evaluation parameters MCQs With Answer

This question set on preclinical drug evaluation parameters is tailored for M.Pharm students preparing for exams and competitive assessments. It covers core concepts such as toxicity testing (acute, subacute, chronic), safety pharmacology, pharmacokinetics (AUC, Cmax, Tmax, clearance), pharmacodynamics, genotoxicity and carcinogenicity assays, GLP/OECD principles, dose scaling and biomarkers. Each multiple-choice question is designed to probe understanding of study objectives, study design, interpretation of endpoints (NOAEL, LD50, MTD, therapeutic index), and the appropriate use of in vitro and in vivo models. Use these MCQs to test knowledge, identify gaps, and reinforce decision-making skills required for preclinical development and regulatory submissions.

Q1. What is the primary objective of preclinical drug evaluation?

• To determine commercial pricing and market strategy
• To evaluate safety and toxicity in appropriate animal models before human trials
• To conduct phase IV post-marketing surveillance
• To finalize clinical trial patient recruitment criteria

Correct Answer: To evaluate safety and toxicity in appropriate animal models before human trials

Q2. LD50 in toxicology refers to:

• The lowest dose producing any observable effect
• The dose producing therapeutic effect in 50% of animals
• The dose that causes death in 50% of the treated animals
• The dose that produces no adverse effects

Correct Answer: The dose that causes death in 50% of the treated animals

Q3. NOAEL stands for:

• No Observed Effect Level
• No Observable Adverse Effect Level
• New Onset Acute Effect Level
• Normal Observed Activity and Effect Level

Correct Answer: No Observable Adverse Effect Level

Q4. OECD guidelines in preclinical studies primarily provide:

• Ethical rules for human clinical trials
• Standards for good clinical practice (GCP)
• Standardized protocols and recommendations for toxicity testing of chemicals and pharmaceuticals
• Marketing authorization procedures for generics

Correct Answer: Standardized protocols and recommendations for toxicity testing of chemicals and pharmaceuticals

Q5. MTD in preclinical toxicity testing means:

• Maximum therapeutic dose for humans
• Most tolerable dilution
• Maximum tolerated dose that produces acceptable but reversible toxicity
• Minimum toxic dose

Correct Answer: Maximum tolerated dose that produces acceptable but reversible toxicity

Q6. Which pharmacokinetic parameter best represents the extent of drug absorption?

• Time to reach peak concentration (Tmax)
• Maximum plasma concentration (Cmax)
• Area under the concentration-time curve (AUC)
• Half-life (t1/2)

Correct Answer: Area under the concentration-time curve (AUC)

Q7. Which parameter is commonly used to assess the rate of drug absorption?

• Volume of distribution (Vd)
• Time to reach maximum plasma concentration (Tmax)
• Area under the curve (AUC)
• Clearance (Cl)

Correct Answer: Time to reach maximum plasma concentration (Tmax)

Q8. Therapeutic index is best defined as:

• Ratio of effective concentration to toxic concentration in vitro
• Ratio of toxic dose to effective dose (TD50/ED50)
• Difference between maximum tolerated dose and minimum effective dose
• Area between dose-response curves of two drugs

Correct Answer: Ratio of toxic dose to effective dose (TD50/ED50)

Q9. Good Laboratory Practice (GLP) in preclinical studies ensures:

• Ethical review of human clinical protocols
• Quality, consistency and integrity of non-clinical safety study data
• Marketing authorization timelines
• Patent protection of new chemical entities

Correct Answer: Quality, consistency and integrity of non-clinical safety study data

Q10. Which assay is widely used to detect bacterial mutagenicity (genotoxicity) in preclinical evaluation?

• Comet assay in mammalian cells
• Ames bacterial reverse mutation assay
• Micronucleus test in rodents
• Chromosomal aberration test in cultured cells

Correct Answer: Ames bacterial reverse mutation assay

Q11. The most definitive method to identify target organ toxicity in animal studies is:

• Clinical observation only
• Histopathological examination of tissues
• Single time-point clinical chemistry measurement
• Behavioral scoring scales

Correct Answer: Histopathological examination of tissues

Q12. Allometric scaling in preclinical research is primarily used for:

• Comparing in vitro potency between compounds
• Extrapolating pharmacokinetic parameters or doses between species using body size relationships
• Designing randomized controlled trials in humans
• Measuring toxic endpoints in cell cultures

Correct Answer: Extrapolating pharmacokinetic parameters or doses between species using body size relationships

Q13. Which statement correctly distinguishes NOEL from NOAEL?

• NOEL refers to no observed effect level; NOAEL refers to no observed adverse effect level
• NOEL is always higher than NOAEL
• NOAEL refers to no pharmacological effect level; NOEL refers to no adverse effect level
• NOEL and NOAEL are interchangeable terms

Correct Answer: NOEL refers to no observed effect level; NOAEL refers to no observed adverse effect level

Q14. Safety pharmacology core battery typically evaluates potential adverse effects on which organ systems?

• Endocrine, reproductive and integumentary systems
• Central nervous, cardiovascular and respiratory systems
• Gastrointestinal, hepatic and renal systems
• Skeletal, muscular and lymphatic systems

Correct Answer: Central nervous, cardiovascular and respiratory systems

Q15. ADME studies in preclinical evaluation encompass which processes?

• Absorption, Distribution, Metabolism, Excretion
• Adsorption, Degradation, Manufacturing, Evaluation
• Antigenicity, Dosimetry, Metastasis, Elimination
• Administration, Dilution, Mixing, Encapsulation

Correct Answer: Absorption, Distribution, Metabolism, Excretion

Q16. In preclinical development, a biomarker is best described as:

• A subjective clinical score reported by investigators
• An in vitro test reagent used for formulation
• A measurable indicator of biological processes, pharmacologic responses, or toxicity
• A manufacturing impurity marker

Correct Answer: A measurable indicator of biological processes, pharmacologic responses, or toxicity

Q17. Standard long-term carcinogenicity studies in rodents are typically conducted over:

• 28 days
• 90 days
• One year
• Two years

Correct Answer: Two years

Q18. Which in vitro assay is commonly used to assess cytotoxicity of a candidate compound?

• Western blot for plasma proteins
• MTT (tetrazolium) assay for cell viability/cytotoxicity
• ELISA for cytokine profiling only
• Patch-clamp recording in intact animals

Correct Answer: MTT (tetrazolium) assay for cell viability/cytotoxicity

Q19. Acute toxicity studies in animals usually involve:

• Repeated dosing for 6 months
• Single dose administration with 14-day observation for mortality and clinical signs
• Continuous infusion for 30 days
• Three-generation reproductive evaluation

Correct Answer: Single dose administration with 14-day observation for mortality and clinical signs

Q20. In pharmacokinetics, clearance (Cl) is defined as:

• Time taken for plasma concentration to reduce by half
• Volume of plasma completely cleared of drug per unit time
• Maximum concentration achieved after dosing
• Ratio of AUC to dose

Correct Answer: Volume of plasma completely cleared of drug per unit time

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