MPharm Master of Pharmacy Master of Pharmacy: Research and Biostatistics 2 — Questions and Answers
Question 1: In a randomized controlled trial, what does 'allocation concealment' prevent?
- Selection bias during participant assignment (Correct answer)
- Performance bias after randomization
- Detection bias during outcome measurement
- Attrition bias from dropouts
Correct answer: Selection bias during participant assignment
Allocation concealment prevents selection bias by ensuring the investigator cannot predict or influence which group a participant is assigned to before enrollment.
Question 2: A 95% confidence interval for a drug's mean reduction in blood pressure is (8 mmHg, 14 mmHg). What is the correct interpretation?
- We are 95% confident the true population mean reduction falls between 8 and 14 mmHg (Correct answer)
- There is a 95% probability the sample mean is between 8 and 14 mmHg
- 95% of individual patients will have a reduction between 8 and 14 mmHg
- The drug works in 95% of patients
Correct answer: We are 95% confident the true population mean reduction falls between 8 and 14 mmHg
A 95% CI means that if the study were repeated many times, 95% of such intervals would contain the true population parameter.
Question 3: Which study design provides the strongest evidence for causal inference in pharmaceutical research?
- Double-blind randomized controlled trial (Correct answer)
- Prospective cohort study
- Case-control study
- Cross-sectional survey
Correct answer: Double-blind randomized controlled trial
A double-blind RCT controls for both selection bias and performance/detection bias, providing the highest level of evidence for causality.
Question 4: The Kaplan-Meier method is specifically used to analyze which type of data?
- Time-to-event (survival) data with censored observations (Correct answer)
- Continuous normally distributed biomarker data
- Categorical dose-response data
- Repeated measures laboratory values
Correct answer: Time-to-event (survival) data with censored observations
Kaplan-Meier analysis estimates survival functions from time-to-event data, properly accounting for censored observations.
Question 5: In pharmacokinetic research, a two-compartment model assumes drug distributes between which compartments?
- Central (plasma) and peripheral (tissue) compartments (Correct answer)
- Hepatic and renal compartments
- Intravascular and intracellular compartments
- Gastric and intestinal compartments
Correct answer: Central (plasma) and peripheral (tissue) compartments
A two-compartment model describes drug distribution between a central (blood/plasma) compartment and a peripheral (tissue) compartment with different rate constants.
Question 6: When comparing means across three or more independent groups in pharmaceutical research, the appropriate initial statistical test is:
- One-way ANOVA (Correct answer)
- Independent samples t-test
- Chi-square test
- Wilcoxon rank-sum test
Correct answer: One-way ANOVA
One-way ANOVA simultaneously compares means across three or more groups while controlling the overall Type I error rate.
Question 7: In a bioequivalence study, two formulations are considered bioequivalent if the 90% CI for the geometric mean ratio of AUC and Cmax falls within:
- 80.00%–125.00% (Correct answer)
- 75.00%–133.33%
- 85.00%–117.65%
- 90.00%–111.11%
Correct answer: 80.00%–125.00%
The FDA requires the 90% CI for AUC and Cmax ratios to fall within 80.00%–125.00% to establish bioequivalence for most drugs.
MPharm Master of Pharmacy Master of Pharmacy: Research and Biostatistics 2
In a randomized controlled trial, what does 'allocation concealment' prevent?