Targeted clinical investigations for drug safety MCQs With Answer

Targeted clinical investigations for drug safety focus on systematic assessment of adverse drug reactions, therapeutic drug monitoring, biomarkers, and drug–drug interactions to protect patients and support regulatory decisions. For B.Pharm students, understanding pharmacovigilance principles, safety endpoints, bioanalytical methods (HPLC/LC‑MS), causality assessment (Naranjo, WHO‑UMC), and special population considerations (pediatrics, geriatrics, hepatic/renal impairment) is essential. These investigations integrate clinical labs (LFTs, renal panels, ECG), pharmacokinetics/pharmacodynamics, and post‑marketing surveillance to detect, quantify, and mitigate risks. Mastery of these topics helps pharmacists contribute to safety assessment, risk management plans, and signal detection. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary goal of targeted clinical investigations for drug safety?

• To identify and characterize adverse drug reactions and safety signals
• To determine the commercial price of a drug
• To maximize drug sales through marketing
• To measure patient satisfaction with packaging

Correct Answer: To identify and characterize adverse drug reactions and safety signals

Q2. Which laboratory test is most commonly monitored in suspected drug‑induced liver injury (DILI)?

• Serum alanine aminotransferase (ALT)
• Serum amylase
• Fasting blood glucose
• Thyroid stimulating hormone (TSH)

Correct Answer: Serum alanine aminotransferase (ALT)

Q3. Therapeutic drug monitoring (TDM) is most useful for drugs that have:

• Narrow therapeutic index and variable pharmacokinetics
• High therapeutic index and predictable kinetics
• Only topical use
• No measurable plasma concentration

Correct Answer: Narrow therapeutic index and variable pharmacokinetics

Q4. Which method is a gold standard for quantitative drug measurement in plasma for safety studies?

• LC‑MS/MS (liquid chromatography‑tandem mass spectrometry)
• Thin layer chromatography
• Immunodiffusion
• Colorimetric urine strip

Correct Answer: LC‑MS/MS (liquid chromatography‑tandem mass spectrometry)

Q5. Which causality assessment tool is commonly used in pharmacovigilance to assess relationship between drug and adverse event?

• Naranjo algorithm
• APACHE II score
• Glasgow Coma Scale
• Framingham Risk Score

Correct Answer: Naranjo algorithm

Q6. A prolonged QT interval is best evaluated by which targeted clinical investigation?

• Serial ECG monitoring with QTc calculation
• Chest X‑ray
• Serum bilirubin measurement
• Urine culture

Correct Answer: Serial ECG monitoring with QTc calculation

Q7. Which biomarker is most specific for myocardial injury in safety monitoring?

• Cardiac troponin I or T
• ALT
• Creatine kinase‑MB fraction is obsolete
• CRP (C‑reactive protein)

Correct Answer: Cardiac troponin I or T

Q8. In targeted investigations, pharmacokinetic sampling to determine AUC and Cmax helps assess:

• Systemic exposure related to safety and toxicity
• Patient adherence to diet
• Drug marketing strategy
• Device compatibility only

Correct Answer: Systemic exposure related to safety and toxicity

Q9. Which population often requires dose adjustment and special safety monitoring due to altered drug clearance?

• Patients with renal impairment
• Healthy young adults
• Patients with seasonal allergies only
• Patients taking vitamins

Correct Answer: Patients with renal impairment

Q10. Signal detection in pharmacovigilance primarily uses:

• Spontaneous adverse event reports and data mining of databases
• Only randomized controlled trials
• Marketing surveys about drug color
• Pharmaceutical packaging tests

Correct Answer: Spontaneous adverse event reports and data mining of databases

Q11. Which regulatory phase is most associated with post‑marketing safety surveillance?

• Phase IV clinical studies
• Phase I first‑in‑human trials
• Preclinical animal testing
• Phase II exploratory efficacy studies

Correct Answer: Phase IV clinical studies

Q12. Monitoring for agranulocytosis requires assessment of which parameter?

• Absolute neutrophil count (ANC)
• Platelet mean volume
• Serum sodium
• PT/INR

Correct Answer: Absolute neutrophil count (ANC)

Q13. What is the role of genotyping in targeted safety investigations?

• Identifying patients with variants affecting drug metabolism (e.g., CYP450)
• Determining product expiration date
• Measuring drug potency in tablets
• Assessing packaging integrity

Correct Answer: Identifying patients with variants affecting drug metabolism (e.g., CYP450)

Q14. MedDRA terminology is important in safety reporting because it:

• Provides standardized coding for adverse events
• Measures drug concentration in plasma
• Defines marketing categories for drugs
• Standardizes tablet dissolution

Correct Answer: Provides standardized coding for adverse events

Q15. Which test is most relevant when investigating suspected drug‑induced kidney injury?

• Serum creatinine and estimated glomerular filtration rate (eGFR)
• Serum amylase
• Fasting lipid profile
• Serum calcium only

Correct Answer: Serum creatinine and estimated glomerular filtration rate (eGFR)

Q16. In targeted safety studies, a therapeutic index (TI) is defined as:

• Ratio of toxic dose to effective dose
• Time to reach steady state
• Rate of absorption in intestine
• Number of adverse events reported per month

Correct Answer: Ratio of toxic dose to effective dose

Q17. Which approach is used to assess immune‑mediated adverse reactions such as hypersensitivity?

• Immunogenicity assays and specific antibody testing
• Urinalysis for ketones
• HPLC to determine tablet content
• Visual inspection of blister packs

Correct Answer: Immunogenicity assays and specific antibody testing

Q18. Which parameter is crucial when monitoring anticoagulant safety for drugs like warfarin?

• INR (international normalized ratio)
• Serum potassium
• Fasting blood sugar
• Serum magnesium

Correct Answer: INR (international normalized ratio)

Q19. Drug–drug interaction assessment in targeted investigations commonly evaluates effects on:

• CYP450 enzyme activity and transporter function
• Tablet color changes
• Package leaflet readability
• Water solubility at room temperature

Correct Answer: CYP450 enzyme activity and transporter function

Q20. Which guideline series covers clinical safety reporting of adverse events to regulators?

• ICH E2A/E2D guidelines on clinical safety data management
• ICH Q1A on stability testing
• WHO Good Storage Practices
• USP monographs

Correct Answer: ICH E2A/E2D guidelines on clinical safety data management

Q21. In pediatric safety studies, dosing and monitoring differ mainly because:

• Children have different pharmacokinetics and developmental physiology
• Children always tolerate higher doses than adults
• No laboratory monitoring is required
• Adults and children are identical pharmacologically

Correct Answer: Children have different pharmacokinetics and developmental physiology

Q22. A signal that a drug may cause QT prolongation would most likely prompt which step?

• Intensive ECG monitoring and thorough QT (TQT) or focused studies
• Immediate product withdrawal without investigation
• Changing tablet color to warn patients
• Increasing marketing to high‑risk groups

Correct Answer: Intensive ECG monitoring and thorough QT (TQT) or focused studies

Q23. Which analytic validation parameter ensures an assay consistently yields similar results on repeated testing?

• Precision
• Specificity
• Recovery
• Stability only

Correct Answer: Precision

Q24. For biologic drugs, targeted safety investigations often emphasize:

• Immunogenicity and neutralizing antibody detection
• Tablet hardness testing
• Color matching of vials
• Osmolality of packaging solution only

Correct Answer: Immunogenicity and neutralizing antibody detection

Q25. Which metric is used to quantify a safety signal’s strength in database mining?

• Reporting Odds Ratio (ROR) or proportional reporting ratio (PRR)
• Body mass index (BMI)
• Half‑life in hours
• Tablet dissolution time in minutes

Correct Answer: Reporting Odds Ratio (ROR) or proportional reporting ratio (PRR)

Q26. Which safety endpoint is most relevant for drugs with hepatotoxic potential during clinical monitoring?

• ALT/AST elevation and bilirubin increases
• Platelet count only
• Serum uric acid levels
• Arterial blood gas

Correct Answer: ALT/AST elevation and bilirubin increases

Q27. Pregnancy exposure registries in post‑marketing safety aim to:

• Collect data about fetal and maternal outcomes after drug exposure
• Evaluate tablet coating durability
• Test new manufacturing equipment
• Measure consumer satisfaction with leaflets

Correct Answer: Collect data about fetal and maternal outcomes after drug exposure

Q28. Which adverse event coding dictionary is routinely used for global safety reporting?

• MedDRA (Medical Dictionary for Regulatory Activities)
• ICD‑10 for laboratory assays
• CAS registry numbers for safety events
• ATC codes for adverse events

Correct Answer: MedDRA (Medical Dictionary for Regulatory Activities)

Q29. In evaluating hepatotoxicity, Hy’s law is applied to predict:

• Risk of serious liver injury when ALT/AST are elevated with bilirubin increase
• Likelihood of renal stones formation
• Probability of QTc shortening
• Rate of drug absorption in stomach

Correct Answer: Risk of serious liver injury when ALT/AST are elevated with bilirubin increase

Q30. Which strategy can reduce risk of adverse events from narrow therapeutic index drugs?

• Individualized dosing guided by TDM and clinical monitoring
• Ignoring drug interactions and increasing dose
• Giving the same dose to all patients regardless of condition
• Reducing labeling and patient counseling

Correct Answer: Individualized dosing guided by TDM and clinical monitoring

G S Sachin

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.

Mail- Sachin@pharmacyfreak.com