Personalized medicine: definition and concepts MCQs With Answer

Personalized medicine: definition and concepts MCQs With Answer is designed for M. Pharm (MPH 102T: Drug Delivery Systems) students to strengthen conceptual clarity and exam readiness. This set focuses on how genomics, biomarkers, and phenotypic data guide individualized therapy selection, dosing, and delivery. You will explore predictive versus prognostic biomarkers, companion diagnostics, theranostics, adaptive trial designs, and the integration of therapeutic drug monitoring (TDM) with population PK/Bayesian methods. The questions also touch on ligand-directed and stimuli-responsive delivery systems, regulatory expectations, and ethical considerations around data privacy. Each MCQ includes a clear answer to support self-assessment and quick revision, while emphasizing practical, clinically relevant applications of personalized medicine in modern drug delivery.

Q1. Which statement best defines personalized medicine?

• Tailoring prevention, diagnosis, and therapy using individual genomic, biomarker, phenotypic, and environmental information
• Developing a unique drug for every individual regardless of disease similarities
• Using average population dosing to simplify prescribing
• Treating only based on patient preferences without scientific data

Correct Answer: Tailoring prevention, diagnosis, and therapy using individual genomic, biomarker, phenotypic, and environmental information

Q2. Which component most directly enables personalized medicine within drug delivery systems?

• Pharmacogenomics and multi-omics integration to guide drug choice and dosing
• Conventional epidemiology without patient-level data
• Histology alone without molecular profiling
• Anecdotal clinical experience

Correct Answer: Pharmacogenomics and multi-omics integration to guide drug choice and dosing

Q3. Which is a predictive biomarker (i.e., predicts response to a specific therapy)?

• EGFR exon 19 deletion in NSCLC guiding EGFR TKI therapy
• Tumor size at diagnosis
• Age above 65 years
• Elevated alkaline phosphatase indicating cholestasis

Correct Answer: EGFR exon 19 deletion in NSCLC guiding EGFR TKI therapy

Q4. Which is a classic example of a companion diagnostic–drug pair?

• HER2 overexpression testing to select trastuzumab in breast cancer
• HbA1c measurement to diagnose diabetes before metformin
• Blood pressure reading before starting ACE inhibitors
• Pulse oximetry before salbutamol inhaler

Correct Answer: HER2 overexpression testing to select trastuzumab in breast cancer

Q5. Which genetic factors are commonly incorporated into warfarin dosing algorithms?

• VKORC1 and CYP2C9 (often with CYP4F2) in dosing algorithms
• HLA-B*57:01 and CCR5
• EGFR and ALK
• CYP3A5 and SLCO1B1 exclusively

Correct Answer: VKORC1 and CYP2C9 (often with CYP4F2) in dosing algorithms

Q6. Before initiating abacavir, what testing is recommended to prevent serious hypersensitivity?

• HLA-B*57:01 genotyping prior to therapy
• CYP2D6 phenotyping
• UGT1A1*28 genotyping
• HLA-B*15:02 testing

Correct Answer: HLA-B*57:01 genotyping prior to therapy

Q7. Which statement about clopidogrel and pharmacogenomics is correct?

• Loss-of-function CYP2C19 alleles reduce activation and increase adverse cardiovascular events with standard dosing
• CYP2D6 variants increase activation of clopidogrel to morphine
• VKORC1 variants increase bleeding risk with clopidogrel
• HLA-B*15:02 predicts SJS/TEN with clopidogrel

Correct Answer: Loss-of-function CYP2C19 alleles reduce activation and increase adverse cardiovascular events with standard dosing

Q8. Which personalized medicine issue is most relevant to codeine safety?

• CYP2D6 ultra-rapid metabolizers risk life-threatening morphine toxicity at standard doses
• CYP2C19 poor metabolizers will not respond to codeine
• UGT1A1*28 carriers cannot form morphine-6-glucuronide
• TPMT deficiency increases codeine toxicity

Correct Answer: CYP2D6 ultra-rapid metabolizers risk life-threatening morphine toxicity at standard doses

Q9. What is the key pharmacogenetic consideration for thiopurines (azathioprine/6-MP)?

• Reduced TPMT or NUDT15 activity necessitates substantial thiopurine dose reduction to avoid myelosuppression
• CYP3A5 poor metabolizers require higher azathioprine doses
• HLA-B*57:01 predicts azathioprine-induced rash
• EGFR mutation predicts thioguanine response

Correct Answer: Reduced TPMT or NUDT15 activity necessitates substantial thiopurine dose reduction to avoid myelosuppression

Q10. Which statement best captures the relationship among “personalized,” “precision,” and “stratified” medicine?

• Precision and personalized medicine are often used interchangeably; in practice many interventions are stratified by biomarker-defined subgroups rather than unique per individual
• Personalized medicine strictly requires a bespoke drug made for each patient
• Stratified medicine ignores biomarkers
• Precision medicine excludes environmental factors

Correct Answer: Precision and personalized medicine are often used interchangeably; in practice many interventions are stratified by biomarker-defined subgroups rather than unique per individual

Q11. Which statement correctly distinguishes basket and umbrella clinical trials?

• Basket trials enroll different tumor types sharing a driver mutation; umbrella trials test multiple targeted therapies within one cancer type subdivided by biomarkers
• Basket trials test multiple drugs in one cancer type; umbrella trials test one drug in many cancer types
• Basket trials and umbrella trials are identical designs
• Basket trials are always randomized; umbrella trials are always single-arm

Correct Answer: Basket trials enroll different tumor types sharing a driver mutation; umbrella trials test multiple targeted therapies within one cancer type subdivided by biomarkers

Q12. What does “theranostics” mean in the context of personalized medicine?

• Integrating diagnostic imaging/biomarkers with targeted therapy selection and sometimes payload delivery in the same platform
• Designing long-acting depot formulations to improve adherence
• Using two drugs simultaneously without testing
• Only an imaging technique without therapeutic implications

Correct Answer: Integrating diagnostic imaging/biomarkers with targeted therapy selection and sometimes payload delivery in the same platform

Q13. Which is a recognized theranostic pair used to personalize radionuclide therapy?

• 68Ga-DOTATATE PET to select 177Lu-DOTATATE therapy in neuroendocrine tumors
• CT scan to choose cisplatin for all solid tumors
• MRI to guide metformin selection in diabetes
• HbA1c to guide the type of insulin pen device

Correct Answer: 68Ga-DOTATATE PET to select 177Lu-DOTATATE therapy in neuroendocrine tumors

Q14. In targeted drug delivery, what best describes active targeting?

• Decorating carriers with ligands that bind overexpressed receptors on target cells to enhance uptake
• Relying solely on the EPR effect without surface ligands
• Using larger particles to reduce clearance
• Increasing dose to drive tissue penetration

Correct Answer: Decorating carriers with ligands that bind overexpressed receptors on target cells to enhance uptake

Q15. What characterizes stimuli-responsive (smart) drug delivery systems in personalized medicine?

• pH-, redox-, enzyme-, or temperature-sensitive carriers that release drug in response to local triggers
• Immediate-release tablets designed only for rapid onset
• Sugar-coated tablets primarily for palatability
• Use of colorants to improve capsule aesthetics

Correct Answer: pH-, redox-, enzyme-, or temperature-sensitive carriers that release drug in response to local triggers

Q16. In which scenario is therapeutic drug monitoring (TDM) central to personalization regardless of genotype?

• Narrow therapeutic index drugs with measurable concentrations (e.g., aminoglycosides, vancomycin)
• Prodrugs requiring CYP2D6 activation
• Medications with wide therapeutic indices and flat dose–response
• OTC analgesics like acetaminophen at recommended doses

Correct Answer: Narrow therapeutic index drugs with measurable concentrations (e.g., aminoglycosides, vancomycin)

Q17. What is the regulatory expectation for companion diagnostics in personalized therapy?

• When a test is essential for the safe and effective use of a drug, regulators require an approved companion diagnostic referenced in the drug label
• Companion diagnostics are optional marketing tools without regulatory oversight
• Only the EMA, not the FDA, regulates companion diagnostics
• Companion diagnostics apply only to cytotoxic chemotherapy

Correct Answer: When a test is essential for the safe and effective use of a drug, regulators require an approved companion diagnostic referenced in the drug label

Q18. Which best exemplifies data integration for personalized prescribing in clinical decision support?

• Genomic variants, biomarkers, EHR phenotype, and PK data integrated to recommend drug and dose
• Country of residence used alone to select therapy
• Social media activity guiding drug choice
• Blood group used alone for all prescriptions

Correct Answer: Genomic variants, biomarkers, EHR phenotype, and PK data integrated to recommend drug and dose

Q19. What is the principle behind Bayesian adaptive dosing in population PK models?

• Using a prior population PK model updated with individual drug concentrations to personalize dosing in real time
• Assigning the average dose to all patients to reduce variability
• Relying solely on genotype without measuring drug levels
• Limiting application strictly to oncology drugs

Correct Answer: Using a prior population PK model updated with individual drug concentrations to personalize dosing in real time

Q20. How can personalization address interpatient variability in the EPR effect for nanomedicines?

• Image-guided patient selection to confirm carrier accumulation before therapy or to adjust formulation/design
• Assuming the EPR effect is uniform across all tumors
• Choosing the largest nanoparticle size for every patient
• Ignoring differences in tumor perfusion and stromal density

Correct Answer: Image-guided patient selection to confirm carrier accumulation before therapy or to adjust formulation/design

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