Introduction: Bioassay is essential in B. Pharm for evaluating biological activity, potency and safety of drugs. This concise guide covers types of bioassay including in vivo and in vitro methods, graded and quantal assays, comparative designs like parallel line and slope-ratio assays, and modern immunoassays (ELISA). Keywords: bioassay, types of bioassay, bioassay methods, biological standardization, potency, graded assay, quantal assay, parallel line assay, in vivo, in vitro. The questions emphasize assay design, dose-response relationships, statistical validation, sensitivity and specificity to prepare you for exams and practical lab work. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which bioassay type measures response intensity across a range of doses and yields a dose-response curve?
- Quantal bioassay
- Graded bioassay
- Microbial assay
- Immunoassay
Correct Answer: Graded bioassay
Q2. Which assay determines the dose that produces a defined effect in 50% of the population?
- ED50 determination in graded assay
- LD50 determination
- Potency ratio assay
- Absolute bioassay
Correct Answer: ED50 determination in graded assay
Q3. A comparative bioassay that assumes parallel dose-response lines for sample and standard is called:
- Slope-ratio assay
- Parallel line assay
- Single-point assay
- Quantal assay
Correct Answer: Parallel line assay
Q4. Which bioassay type classifies responses as ‘all-or-none’ such as survival versus death?
- Graded bioassay
- Continuous response assay
- Quantal bioassay
- Microbial bioassay
Correct Answer: Quantal bioassay
Q5. The slope-ratio assay is most appropriate when sample and standard dose-response lines are:
- Non-parallel but identical intercepts
- Curvilinear and non-comparable
- Proportional with identical slope
- Parallel with different slopes
Correct Answer: Proportional with identical slope
Q6. Which is a major advantage of in vitro bioassays over in vivo bioassays?
- Better reflection of whole-organism effects
- Lower throughput and higher cost
- Ethical simplicity and higher throughput
- No need for validation
Correct Answer: Ethical simplicity and higher throughput
Q7. In microbial bioassays measuring antibiotic potency, the usual end point is:
- Organ weight change
- Zone of inhibition diameter
- Serum antibody titre
- ED50 in animals
Correct Answer: Zone of inhibition diameter
Q8. Which statistical method is commonly used to analyze quantal dose-response data?
- ANOVA without transformation
- Probit analysis
- Kaplan-Meier estimation
- Chi-square goodness-of-fit only
Correct Answer: Probit analysis
Q9. In a bioassay, ‘potency’ refers to:
- The maximum achievable effect regardless of dose
- The slope of the dose-response curve only
- The dose required to produce a specified effect
- The chemical purity of the drug
Correct Answer: The dose required to produce a specified effect
Q10. Which quality parameter assesses the closeness of repeated bioassay measurements to each other?
- Accuracy
- Specificity
- Precision
- Sensitivity
Correct Answer: Precision
Q11. An absolute bioassay provides:
- Potency relative to a reference standard
- An exact value of biological activity without reference
- Only qualitative presence/absence
- Comparative slope values only
Correct Answer: An exact value of biological activity without reference
Q12. Which assay type is most suitable for hormone receptor-ligand activity in cell lines?
- Microbial assay
- In vivo LD50 test
- Cell-based in vitro bioassay
- Immunodiffusion
Correct Answer: Cell-based in vitro bioassay
Q13. Parallelism between standard and test in a parallel line assay indicates:
- Systematic error in dilution
- Similar pharmacological mechanism and potency comparison valid
- Different mechanisms of action
- That potency cannot be determined
Correct Answer: Similar pharmacological mechanism and potency comparison valid
Q14. The main purpose of using a biological standard in bioassays is to:
- Eliminate need for replicates
- Provide a reference to calculate potency
- Replace assay validation
- Increase assay variability
Correct Answer: Provide a reference to calculate potency
Q15. Which assay provides a rapid, sensitive immunological method for antigen quantitation?
- ELISA
- Parallel line assay
- Whole-animal LD50
- Zone weight assay
Correct Answer: ELISA
Q16. In a slope-ratio assay, the relative potency is estimated from:
- Difference in ED50 values only
- Ratio of slopes when curves pass through origin
- The absolute maximum response values
- Number of replicates used
Correct Answer: Ratio of slopes when curves pass through origin
Q17. Which factor most directly affects sensitivity of a bioassay?
- Number of investigators
- Choice of biological end point and assay conditions
- Color of assay tubes
- Packaging of the standard
Correct Answer: Choice of biological end point and assay conditions
Q18. Validation of a bioassay typically includes assessment of:
- Only linearity
- Precision, accuracy, specificity and sensitivity
- Chemical structure elucidation
- Sterility alone
Correct Answer: Precision, accuracy, specificity and sensitivity
Q19. A potency estimate with wide confidence intervals indicates:
- High precision and reliable assay
- Low precision and high uncertainty
- That the true potency is exactly at the interval midpoint
- Assay specificity is perfect
Correct Answer: Low precision and high uncertainty
Q20. Which design is preferred to reduce biological variability in in vivo bioassays?
- Randomization and sufficient replication
- Always using single animals per group
- No control group to save resources
- Non-blinded allocation based on weight
Correct Answer: Randomization and sufficient replication
Q21. The term ‘specificity’ in bioassay validation refers to:
- The ability to detect any biological response regardless of cause
- The ability to measure the intended analyte without interference
- Higher sensitivity at low concentrations
- The slope of the dose-response curve
Correct Answer: The ability to measure the intended analyte without interference
Q22. Which endpoint measurement is quantitative and commonly used in enzyme-based bioassays?
- Subjective scoring
- Optical density measured by spectrophotometer
- Visual zone observation only
- Animal behavioral score only
Correct Answer: Optical density measured by spectrophotometer
Q23. In a bioassay, ‘linearity’ refers to:
- Constant slope across different assays regardless of dose range
- Proportional relationship between response and concentration over a range
- The parallelism of log-dose curves only
- The absence of any biological response
Correct Answer: Proportional relationship between response and concentration over a range
Q24. Which is a limitation of in vivo bioassays compared to in vitro methods?
- Lower biological relevance
- Lower cost and higher throughput
- Greater ethical concerns and variability
- No requirement for controls
Correct Answer: Greater ethical concerns and variability
Q25. The concept of ‘parallelism’ in dose-response analysis helps to verify:
- That the sample is chemically pure
- That dose-response slopes are significantly different
- That test and standard act via similar mechanisms
- That the assay lacks sensitivity
Correct Answer: That test and standard act via similar mechanisms
Q26. A three-point bioassay typically uses how many doses of test and standard?
- One dose each
- Two doses of each
- Three doses of each
- Unlimited doses
Correct Answer: Three doses of each
Q27. Which assay type is most appropriate to measure antibody concentration in serum?
- Animal LD50 test
- Immunoassay such as ELISA
- Microbial zone assay
- Parallel line pharmacological assay
Correct Answer: Immunoassay such as ELISA
Q28. Which is true when selecting a biological system for a bioassay?
- Choose the cheapest organism irrespective of relevance
- Match the system to the drug’s mechanism and desired end point
- Avoid validation if the system is biologically relevant
- Always use mammalian systems for all drugs
Correct Answer: Match the system to the drug’s mechanism and desired end point
Q29. In dose-response analysis, the term ‘efficacy’ refers to:
- The dose producing 50% effect
- The maximum effect achievable by a drug
- The slope of the dose-response curve only
- The ED50 relative to standard only
Correct Answer: The maximum effect achievable by a drug
Q30. During bioassay reporting, which detail is essential for reproducibility?
- Only the final potency value without methods
- Complete description of method, biological system, doses and statistical analysis
- Names of the lab personnel only
- Brand of consumables used without procedures
Correct Answer: Complete description of method, biological system, doses and statistical analysis

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