Sit a mock against the clock

Single-best-answer MCQs with a countdown timer that auto-submits at zero, then a scored report with explanations. Retake as often as you like.

Rapid Fire — high-yield pharmacology

10 questions8 minPass 60%

Single best answer. The timer starts when you begin and auto-submits at zero. You get a scored report with explanations at the end.

Rapid Fire — high-yield pharmacology8:00

Q1. Which drug is contraindicated in pregnancy (teratogenic)?

Q2. In the event of a clinical-trial-related injury or death, the compensation is paid by the:

Q3. A feature of digoxin toxicity, worsened by hypokalaemia, is:

Q4. Which is first-line in type 2 diabetes and does NOT cause hypoglycaemia?

Q5. Amiodarone belongs to which Vaughan-Williams antiarrhythmic class?

Q6. Which class causes hypercalcaemia by retaining calcium?

Q7. Which long-acting insulin analogue gives a flat basal profile?

Q8. Bioequivalence between a test and reference product is established mainly by comparing:

Q9. Which antipsychotic needs regular white-cell monitoring for agranulocytosis?

Q10. Which is a classic narrow-therapeutic-index drug requiring TDM?

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Grand Mock — mixed pharmacology

20 questions22 minPass 60%

Single best answer. The timer starts when you begin and auto-submits at zero. You get a scored report with explanations at the end.

Grand Mock — mixed pharmacology22:00

Q1. First-generation antihistamines (e.g. diphenhydramine) cause sedation because they:

Q2. Which antibiotic class risks tendon rupture and is avoided in children?

Q3. Bioequivalence between a test and reference product is established mainly by comparing:

Q4. The cornerstone method of pharmacovigilance is:

Q5. Warfarin is monitored by ___ and reversed by ___:

Q6. Amiodarone belongs to which Vaughan-Williams antiarrhythmic class?

Q7. An investigator must report a Serious Adverse Event (SAE) to the sponsor and Ethics Committee within:

Q8. Acyclovir is selectively activated by:

Q9. A non-inferiority trial aims to show the test treatment is:

Q10. The most effective antiemetics for chemotherapy-induced nausea are:

Q11. A p-value < 0.05 conventionally indicates that the result is:

Q12. The antihypertensive of choice in pregnancy is:

Q13. Tetracyclines are contraindicated in young children because they cause:

Q14. Organic nitrates relieve angina mainly by:

Q15. The Investigator’s Brochure (IB) primarily contains:

Q16. Which is first-line in type 2 diabetes and does NOT cause hypoglycaemia?

Q17. The drug of choice for symptomatic bradycardia is:

Q18. Drug of choice for absence seizures:

Q19. A CYP2D6 ultra-rapid metaboliser given codeine is at risk of:

Q20. Which selective beta-1 agonist increases cardiac contractility in cardiogenic shock?

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Clinical Pharmacology & Research

15 questions15 minPass 60%

Single best answer. The timer starts when you begin and auto-submits at zero. You get a scored report with explanations at the end.

Clinical Pharmacology & Research15:00

Q1. Good Manufacturing Practice (GMP) for drugs in India is specified under which Schedule of the Drugs & Cosmetics Rules?

Q2. Bioequivalence between a test and reference product is established mainly by comparing:

Q3. Under ICH-GCP, the document giving the scientific rationale, objectives, design and methodology of a trial is the:

Q4. Valid informed consent in a clinical trial must be:

Q5. The New Drugs and Clinical Trials (NDCT) Rules were notified on:

Q6. A p-value < 0.05 conventionally indicates that the result is:

Q7. Phase IV clinical studies are also known as:

Q8. In the event of a clinical-trial-related injury or death, the compensation is paid by the:

Q9. The National Coordinating Centre for the Pharmacovigilance Programme of India (PvPI) is located at:

Q10. The Investigator’s Brochure (IB) primarily contains:

Q11. To compare the means of two independent, normally distributed groups, the appropriate test is the:

Q12. At the top of the hierarchy of evidence sits the:

Q13. Registration of clinical trials with the CTRI became mandatory in India from:

Q14. An investigator must report a Serious Adverse Event (SAE) to the sponsor and Ethics Committee within:

Q15. The apex authority that approves new drugs and clinical trials in India is:

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Every topic, every format

The questions that actually get asked — organised by topic and by marks. Search a keyword, or open a topic to revise its long essays, short notes, short answers and viva points.

33 topics · 466 questions

1NDCT Rules 2019 & Change from Schedule Y16 Q

Long Essay 10–15 marks

  1. Discuss the NDCT Rules 2019 and how they differ from Schedule Y.
  2. Salient features of NDCT 2019 - timelines, compensation and ethics committees.

Short Notes 5 marks

  1. Deemed approval
  2. Compensation under NDCT 2019
  3. New drug vs investigational new drug
  4. Local clinical trial waiver
  5. Changes from Schedule Y to NDCT
  6. Structure of NDCT 2019

Short Answer 2–3 marks

  1. When were the NDCT Rules notified?
  2. Deemed-approval timeline for an indigenous drug?
  3. How long does a drug remain a 'new drug'?
  4. Which committee led to NDCT 2019?
  5. Which schedule gives the compensation formula?

Viva / MCQ

  1.  Who is the Central Licensing Authority?
  2.  Validity of EC registration?
  3.  MCQ: NDCT 2019 was notified on → 19 March 2019.
2Drugs and Cosmetics Act, 194014 Q

Long Essay 10–15 marks

  1. Describe the D&C Act 1940 - objectives, authorities and important schedules.

Short Notes 5 marks

  1. Schedules H1 / X / M / Y
  2. DTAB and DCC
  3. Spurious vs adulterated vs misbranded drugs
  4. Central Drugs Laboratory, Kolkata
  5. Schedule M / Schedule Y

Short Answer 2–3 marks

  1. Who is the DCGI?
  2. What does Schedule X cover?
  3. What does Schedule M cover?
  4. Define a spurious drug.
  5. What is CDL Kolkata?

Viva / MCQ

  1.  Misbranded vs adulterated?
  2.  What is DTAB?
  3.  MCQ: GMP is in → Schedule M.
3Drug Regulatory Framework in India14 Q

Long Essay 10–15 marks

  1. Describe the drug regulatory framework / new-drug approval in India.

Short Notes 5 marks

  1. CDSCO and its functions
  2. DTAB & DCC
  3. NPPA
  4. Pharmacovigilance Programme of India
  5. Central vs State regulatory functions

Short Answer 2–3 marks

  1. Full form of CDSCO; who heads it?
  2. Which products are licensed centrally?
  3. What is the NPPA?
  4. What does the State Licensing Authority do?
  5. What is SUGAM?

Viva / MCQ

  1.  National PV coordinating centre?
  2.  Outline new-drug approval steps.
  3.  MCQ: New drugs are approved by → CDSCO / DCGI.
4Clinical Trial Forms (CT-08 & CT-11), NDCT 201914 Q

Long Essay 10–15 marks

  1. Application & permission forms under NDCT 2019, with emphasis on CT-08 & CT-11.

Short Notes 5 marks

  1. Form CT-08
  2. Form CT-11
  3. SUGAM portal
  4. NDCT 2019 forms overview
  5. CT-04 / CT-05 / CT-06 logic

Short Answer 2–3 marks

  1. What is Form CT-08?
  2. What is Form CT-11?
  3. Form for import of a trial drug? (CT-18)
  4. Form for marketing a new drug? (CT-23)
  5. CT-05 vs CT-06?

Viva / MCQ

  1.  Difference between CT-05 and CT-08?
  2.  Submission portal?
  3.  MCQ: BA/BE study-centre approval → Form CT-08.
5Academic Clinical Trials12 Q

Long Essay 10–15 marks

  1. Define an academic clinical trial; its provisions under NDCT 2019 and difference from a regulatory trial.

Short Notes 5 marks

  1. Academic clinical trials under NDCT 2019
  2. Academic vs regulatory clinical trial
  3. Role of the Ethics Committee in academic trials

Short Answer 2–3 marks

  1. Does it need DCGI permission?
  2. Defining rule? (2(1)(b))
  3. The 30-day rule?
  4. Can the data be used for marketing?
  5. Which obligations still apply?

Viva / MCQ

  1.  Synonym? (IIT)
  2.  When is DCGI permission still needed?
  3.  MCQ: Academic trial needs → EC approval + intimation to DCGI.
6Types of Ethics Committees: CDSCO & DHR14 Q

Long Essay 10–15 marks

  1. Types of ethics committees in India - registration, composition and functions.

Short Notes 5 marks

  1. EC for clinical trials (CDSCO)
  2. EC for biomedical & health research (DHR)
  3. Composition of an ethics committee
  4. Functions of an ethics committee
  5. CDSCO EC vs DHR EC

Short Answer 2–3 marks

  1. Where register - trial vs observational?
  2. What is NECRBHR?
  3. Validity of EC registration?
  4. Quorum of an EC?
  5. Who chairs an EC and why from outside?

Viva / MCQ

  1.  CDSCO EC forms? (CT-01/02)
  2.  Can one EC hold dual registration?
  3.  MCQ: A clinical-trial EC registers with → CDSCO.
7CTRI Registration Process12 Q

Long Essay 10–15 marks

  1. Describe the CTRI and the process of registering a clinical trial.

Short Notes 5 marks

  1. Clinical Trials Registry - India (CTRI)
  2. Process of clinical trial registration
  3. Importance of trial registration

Short Answer 2–3 marks

  1. Launched - when / by whom?
  2. Mandatory since?
  3. Prospective vs retrospective?
  4. CTRI number format?
  5. Is CTRI a WHO Primary Register?

Viva / MCQ

  1.  Why register a trial?
  2.  Is registration free?
  3.  MCQ: CTRI registration became mandatory → 15 June 2009.
8Basics of Clinical Research & ICH-GCP Principles18 Q

Long Essay 10–15 marks

  1. Enumerate and explain the principles of ICH-GCP.
  2. Describe the phases of a clinical trial.
  3. Historical evolution of research ethics (Nuremberg, Helsinki, Belmont).

Short Notes 5 marks

  1. Phases of clinical trials
  2. Principles of ICH-GCP
  3. Declaration of Helsinki
  4. ALCOA / data integrity
  5. ICH (organisation & Q/S/E/M)
  6. Types of clinical research
  7. Objectives of GCP

Short Answer 2–3 marks

  1. Full forms ICH & GCP?
  2. How many GCP principles?
  3. Which ICH guideline is GCP? (E6)
  4. Two objectives of GCP?
  5. Define Phase 0 / microdosing.

Viva / MCQ

  1.  Phase II vs III?
  2.  Who issues the Declaration of Helsinki? (WMA)
  3.  MCQ: GCP is ICH guideline → E6.
9Roles of PI, Co-I, CRC & Sponsor15 Q

Long Essay 10–15 marks

  1. Responsibilities of the Principal Investigator (ICH-GCP 4).
  2. Responsibilities of the sponsor (ICH-GCP 5).

Short Notes 5 marks

  1. Responsibilities of the PI
  2. Role of the sponsor
  3. CRC vs CRA
  4. Role of the Co-investigator
  5. Role of the CRC

Short Answer 2–3 marks

  1. Define 'investigator'.
  2. What is a delegation log?
  3. Who is responsible for informed consent?
  4. Who pays compensation & who decides causality?
  5. Can the sponsor delegate to a CRO?

Viva / MCQ

  1.  CRC vs CRA?
  2.  What is Form FDA 1572?
  3.  MCQ: Ultimate site responsibility → the PI.
10Informed Consent in Clinical Trials13 Q

Long Essay 10–15 marks

  1. Discuss informed consent - process, components, essential elements and special situations.

Short Notes 5 marks

  1. Informed consent
  2. Essential elements of consent
  3. Consent in vulnerable populations
  4. Audio-visual consent

Short Answer 2–3 marks

  1. The three components?
  2. When is it obtained (relative to procedures)?
  3. Consent for an illiterate subject?
  4. When is re-consent needed?
  5. What is an LAR?

Viva / MCQ

  1.  Define informed consent.
  2.  Who signs for an illiterate subject?
  3.  MCQ: Consent is taken → before any trial procedure.
11Clinical Trial Protocol, Amendments & Deviations12 Q

Long Essay 10–15 marks

  1. Discuss protocol design; differentiate protocol violation and deviation with examples.

Short Notes 5 marks

  1. Clinical trial protocol
  2. Contents of a protocol
  3. Protocol amendment
  4. Protocol deviation vs violation

Short Answer 2–3 marks

  1. What is a protocol?
  2. Approval needed for an amendment?
  3. Deviation vs violation?
  4. Exception to amendment pre-approval? (immediate hazard)

Viva / MCQ

  1.  Give a deviation example.
  2.  Give a violation example.
  3.  MCQ: A protocol amendment needs → EC + regulatory approval.
12Clinical Trial Designs12 Q

Long Essay 10–15 marks

  1. Describe clinical trial designs (parallel / crossover / factorial; superiority / non-inferiority).

Short Notes 5 marks

  1. Crossover design
  2. Parallel vs crossover
  3. Non-inferiority trial
  4. Factorial design

Short Answer 2–3 marks

  1. Crossover vs parallel?
  2. What is a washout?
  3. Superiority vs non-inferiority?
  4. Which design is the gold standard?

Viva / MCQ

  1.  Crossover advantages & disadvantages?
  2.  What is carryover?
  3.  MCQ: The gold-standard design → RCT.
13Screening, Enrollment & Randomization15 Q

Long Essay 10–15 marks

  1. Randomisation - methods & importance; allocation concealment vs blinding.

Short Notes 5 marks

  1. Randomisation
  2. Methods of randomisation
  3. Allocation concealment
  4. Stratified / block randomisation
  5. Screening & screen failure
  6. Inclusion & exclusion criteria

Short Answer 2–3 marks

  1. Why randomise?
  2. What is a screen failure?
  3. Allocation concealment vs blinding?
  4. What is minimisation?
  5. When is consent taken?

Viva / MCQ

  1.  Block vs stratified randomisation?
  2.  What is SNOSE?
  3.  MCQ: Allocation concealment protects the assignment → up to allocation.
14Essential Documents in Clinical Trials15 Q

Long Essay 10–15 marks

  1. Define essential documents; classify by trial stage and state their role in GCP compliance.

Short Notes 5 marks

  1. Trial Master File
  2. ISF vs TMF
  3. Investigator's Brochure
  4. Case Report Form
  5. Source documents & ALCOA
  6. Retention of essential documents

Short Answer 2–3 marks

  1. Which ICH-GCP section? (8)
  2. Retention period?
  3. Who maintains TMF / ISF?
  4. Source document vs CRF?
  5. Two post-completion documents?

Viva / MCQ

  1.  Examples of source documents?
  2.  When can documents be destroyed?
  3.  MCQ: Essential documents → ICH-GCP Section 8.
15Source Documents & CRF Filling15 Q

Long Essay 10–15 marks

  1. Source documents and the CRF; ALCOA and data integrity.

Short Notes 5 marks

  1. Source documents
  2. Case Report Form
  3. ALCOA
  4. Source Data Verification
  5. eCRF
  6. Error correction

Short Answer 2–3 marks

  1. What is a source document?
  2. Is the CRF a source document?
  3. How do you correct an error?
  4. What is SDV?
  5. Expand ALCOA.

Viva / MCQ

  1.  Give source-document examples.
  2.  Why is whitener not allowed?
  3.  MCQ: 'If it isn't documented, it → didn't happen.'
16Good Documentation Practices (GDP)12 Q

Long Essay 10–15 marks

  1. Good documentation practices - principles, rules and error correction.

Short Notes 5 marks

  1. Good documentation practices
  2. ALCOA(+)
  3. Error correction in source / CRF
  4. Do's & don'ts of GDP

Short Answer 2–3 marks

  1. The cornerstone principle?
  2. How do you correct an error?
  3. How are blank fields handled?
  4. Which ink is used?

Viva / MCQ

  1.  Why is contemporaneous recording required?
  2.  Why no pencil / whitener?
  3.  MCQ: Records must be → ALCOA(+).
17Investigational Product Handling & Accountability14 Q

Long Essay 10–15 marks

  1. Investigational product handling and drug accountability.

Short Notes 5 marks

  1. Investigational product
  2. Drug accountability
  3. IP storage & temperature control
  4. Labelling of IP
  5. IP destruction

Short Answer 2–3 marks

  1. Define IP.
  2. The reconciliation formula?
  3. Who is responsible at the site?
  4. Storage conditions?
  5. When can IP be destroyed?

Viva / MCQ

  1.  How is blinding maintained?
  2.  Which form to manufacture trial IP? (CT-11)
  3.  MCQ: Investigational product → ICH-GCP 1.33.
18Data Management & Confidentiality16 Q

Long Essay 10–15 marks

  1. Clinical data management and confidentiality.

Short Notes 5 marks

  1. Clinical data management
  2. Database lock
  3. MedDRA
  4. Confidentiality
  5. Subject identification code
  6. Audit trail
  7. CDISC

Short Answer 2–3 marks

  1. What is database lock?
  2. MedDRA vs WHODrug?
  3. Define confidentiality (GCP 1.16).
  4. What is the subject ID code list?
  5. What is 21 CFR Part 11?

Viva / MCQ

  1.  What is an audit trail?
  2.  What is 'direct access'?
  3.  MCQ: Coding of events uses → MedDRA.
19Monitoring, Audits & Inspections16 Q

Long Essay 10–15 marks

  1. Monitoring, audit and inspection - differences and roles.

Short Notes 5 marks

  1. Monitoring
  2. Audit
  3. Inspection
  4. Audit vs inspection
  5. Types of monitoring visits
  6. Risk-based monitoring
  7. Source data verification

Short Answer 2–3 marks

  1. Who monitors a trial?
  2. Are auditors independent of monitors?
  3. Who can inspect?
  4. What is an audit certificate?
  5. What is SDV?

Viva / MCQ

  1.  What are SIV / IMV / COV?
  2.  What is Form FDA 483 / CAPA?
  3.  MCQ: Monitoring is ICH-GCP → 5.18.
20Adverse Event (AE) Reporting14 Q

Long Essay 10–15 marks

  1. Adverse event reporting and causality assessment.

Short Notes 5 marks

  1. AE vs ADR
  2. Serious adverse event
  3. Causality (WHO-UMC / Naranjo)
  4. SUSAR
  5. Severity vs seriousness

Short Answer 2–3 marks

  1. AE vs ADR?
  2. SAE criteria?
  3. Severity vs seriousness?
  4. What is a SUSAR?
  5. Dechallenge & rechallenge?

Viva / MCQ

  1.  WHO-UMC categories?
  2.  Naranjo scoring?
  3.  MCQ: SAE mnemonic → D-L-H-D-C.
21Serious Adverse Event (SAE) Reporting13 Q

Long Essay 10–15 marks

  1. SAE reporting and compensation under NDCT 2019.

Short Notes 5 marks

  1. SAE reporting timelines
  2. Compensation in clinical trials
  3. Definition of an SAE
  4. Role of the EC in SAE reporting

Short Answer 2–3 marks

  1. SAE criteria?
  2. Reporting timeline in India?
  3. Who pays compensation?
  4. Who decides causality?
  5. Consequence of not reporting?

Viva / MCQ

  1.  The reporting cascade?
  2.  SUSAR timelines? (7 / 15 days)
  3.  MCQ: Initial SAE report within → 24 hours.
22Causality Assessment & Compensation14 Q

Long Essay 10–15 marks

  1. Causality assessment methods; OR compensation in clinical trials (NDCT 2019).

Short Notes 5 marks

  1. Naranjo algorithm
  2. WHO-UMC causality scale
  3. Compensation formula
  4. Grounds for compensation
  5. Dechallenge & rechallenge

Short Answer 2–3 marks

  1. Dechallenge & rechallenge?
  2. Naranjo scoring?
  3. Who decides causality?
  4. Compensation formula & base amount?
  5. Who pays?

Viva / MCQ

  1.  WHO-UMC categories?
  2.  Free medical management?
  3.  MCQ: Death-compensation formula → (B x F x R) / 99.37.
23Pharmacovigilance & PvPI in India15 Q

Long Essay 10–15 marks

  1. Pharmacovigilance / the Pharmacovigilance Programme of India.

Short Notes 5 marks

  1. PvPI
  2. Spontaneous reporting
  3. Signal
  4. Materiovigilance
  5. Methods of pharmacovigilance
  6. ADR reporting form

Short Answer 2–3 marks

  1. Define pharmacovigilance (WHO).
  2. Who runs PvPI / where is the NCC?
  3. What is VigiBase?
  4. What is a signal?
  5. Which event began pharmacovigilance? (Thalidomide)

Viva / MCQ

  1.  VigiFlow vs VigiBase?
  2.  PSUR vs DSUR?
  3.  MCQ: PvPI NCC → IPC, Ghaziabad.
24Post-Marketing Surveillance (Phase IV)14 Q

Long Essay 10–15 marks

  1. Post-marketing surveillance / Phase IV studies.

Short Notes 5 marks

  1. Post-marketing surveillance
  2. Phase IV trial
  3. PSUR
  4. REMS
  5. Prescription Event Monitoring

Short Answer 2–3 marks

  1. Why is PMS needed?
  2. Methods of PMS?
  3. What is PEM?
  4. PSUR schedule under NDCT?
  5. Example of a drug withdrawn post-marketing?

Viva / MCQ

  1.  What are the 'too's of pre-marketing trials?
  2.  What is an RMP?
  3.  MCQ: Post-marketing studies are → Phase IV.
25Drug Discovery Process14 Q

Long Essay 10–15 marks

  1. Steps in drug discovery and development.

Short Notes 5 marks

  1. Target identification & validation
  2. High-throughput screening (HTS)
  3. Lipinski's Rule of Five
  4. Preclinical development
  5. Approaches to drug discovery

Short Answer 2–3 marks

  1. Average time & cost?
  2. What is target validation?
  3. What is HTS?
  4. Sources of drugs?
  5. What is CADD?

Viva / MCQ

  1.  GLP vs CPCSEA?
  2.  Define a lead compound.
  3.  MCQ: Lipinski MW limit → 500.
26Drug Development: Lead Identification & Validation14 Q

Long Essay 10–15 marks

  1. Define hit and lead; describe lead identification, validation and optimisation.

Short Notes 5 marks

  1. Lead compound
  2. Lead optimisation
  3. Structure-activity relationship (SAR)
  4. Lipinski's Rule of Five
  5. Methods of lead identification

Short Answer 2–3 marks

  1. Hit vs lead?
  2. What is lead validation?
  3. What makes a good lead?
  4. What is SAR?
  5. State Lipinski's Rule of Five.

Viva / MCQ

  1.  Fragment-based discovery?
  2.  Drug repurposing?
  3.  MCQ: A prototype with desired activity but suboptimal properties → lead.
27Bioavailability & Bioequivalence (BA/BE) Studies14 Q

Long Essay 10–15 marks

  1. Bioavailability and bioequivalence studies - definitions, design and criteria.

Short Notes 5 marks

  1. Bioavailability
  2. Bioequivalence
  3. BCS
  4. Biowaiver
  5. PK parameters (Cmax / Tmax / AUC)

Short Answer 2–3 marks

  1. Define BA & BE.
  2. Which PK parameters?
  3. BE acceptance criteria?
  4. Study design?
  5. What is a biowaiver?

Viva / MCQ

  1.  Absolute vs relative BA?
  2.  BCS Class I?
  3.  MCQ: BE criterion - 90% CI within → 80-125%.
28Therapeutic Drug Monitoring (TDM)11 Q

Long Essay 10–15 marks

  1. Therapeutic drug monitoring - indications, drugs and sampling.

Short Notes 5 marks

  1. TDM - indications & limitations
  2. Drugs requiring TDM

Short Answer 2–3 marks

  1. Define TDM.
  2. Which drugs need it?
  3. When do you sample?
  4. Why for narrow-TI drugs?
  5. Trough vs peak sampling?

Viva / MCQ

  1.  Digoxin therapeutic range?
  2.  What is steady state?
  3.  MCQ: Aminoglycosides need → peak & trough.
29Pharmacogenetics & Pharmacogenomics12 Q

Long Essay 10–15 marks

  1. Pharmacogenetics - genetic polymorphisms influencing drug response; role in drug development & clinical practice.

Short Notes 5 marks

  1. Pharmacogenomics vs pharmacogenetics
  2. Acetylator status
  3. HLA & drug reactions

Short Answer 2–3 marks

  1. Define pharmacogenetics.
  2. NAT2 & isoniazid?
  3. TPMT & azathioprine?
  4. HLA-B*1502 & which drug?
  5. G6PD & which drugs?

Viva / MCQ

  1.  Succinylcholine & pseudocholinesterase?
  2.  Warfarin genes? (CYP2C9/VKORC1)
  3.  MCQ: Genome-wide study of drug response → pharmacogenomics.
30CPCSEA & Alternatives to Animal Experiments15 Q

Long Essay 10–15 marks

  1. CPCSEA guidelines; alternatives to animal experiments.

Short Notes 5 marks

  1. CPCSEA
  2. The 3 Rs
  3. Alternatives to animal experiments
  4. CAL
  5. Euthanasia of experimental animals
  6. IAEC

Short Answer 2–3 marks

  1. CPCSEA full form & parent Act?
  2. State the 3 Rs.
  3. What is the IAEC?
  4. Examples of alternatives?
  5. What is CAL?

Viva / MCQ

  1.  Who proposed the 3 Rs? (Russell & Burch)
  2.  What is in-silico testing?
  3.  MCQ: CPCSEA is under → the PCA Act, 1960.
31Biostatistics for Clinical Research18 Q

Long Essay 10–15 marks

  1. Tests of significance / hypothesis testing in clinical research.

Short Notes 5 marks

  1. Type I & II errors
  2. p-value
  3. t-test
  4. ANOVA
  5. Chi-square test
  6. Parametric vs non-parametric
  7. Sample size
  8. Case-control vs cohort
  9. Meta-analysis

Short Answer 2–3 marks

  1. Define the p-value.
  2. Type I vs Type II error?
  3. What is power?
  4. Which test when?
  5. RR vs OR?

Viva / MCQ

  1.  What is a 95% CI?
  2.  Examples of non-parametric tests?
  3.  MCQ: Top of the evidence hierarchy → meta-analysis / systematic review.
32Rational Drug Use, P-drug & Essential Medicines14 Q

Long Essay 10–15 marks

  1. P-drug & rational prescribing; OR essential medicines and the NLEM.

Short Notes 5 marks

  1. P-drug concept
  2. Essential medicines / NLEM
  3. Rational use of drugs
  4. Prescription audit
  5. WHO prescribing indicators

Short Answer 2–3 marks

  1. Define a P-drug.
  2. P-drug selection criteria?
  3. What is the NLEM?
  4. What makes a prescription rational?
  5. Name a WHO prescribing indicator.

Viva / MCQ

  1.  The WHO 6-step process?
  2.  When was the WHO EML first published? (1977)
  3.  MCQ: India's latest essential-medicines list → NLEM 2022.
33Psychomotor Practical Session: Human Practical Demonstration15 Q

Long Essay 10–15 marks

  1. Psychomotor domain & human practical demonstrations; methods of assessment.

Short Notes 5 marks

  1. Psychomotor domain
  2. Dave's hierarchy
  3. OSPE
  4. Human practicals in pharmacology
  5. Miller's pyramid
  6. P-drug exercise

Short Answer 2–3 marks

  1. Name the domains of learning.
  2. Levels of the psychomotor domain?
  3. What is OSPE?
  4. What is Miller's pyramid?
  5. What is Peyton's 4-step?

Viva / MCQ

  1.  Examples of human practicals?
  2.  What replaced animal experiments in teaching? (CAL)
  3.  MCQ: On Miller's pyramid, OSCE assesses → 'Shows how'.