Q.1 Which agency primarily regulates the approval of biopharmaceuticals in the United States?
European Medicines Agency (EMA)
Food and Drug Administration (FDA)
World Health Organization (WHO)
National Institutes of Health (NIH)
Explanation - In the U.S., the FDA is responsible for reviewing and approving biopharmaceuticals for safety, efficacy, and quality before they can be marketed.
Correct answer is: Food and Drug Administration (FDA)
Q.2 Good Manufacturing Practice (GMP) guidelines are designed to ensure that biopharmaceuticals are:
Produced only in academic labs
Made in a way that guarantees patient confidentiality
Manufactured consistently and with proper quality control
Sold at a lower cost to patients
Explanation - GMP focuses on systematic processes to maintain product quality and consistency throughout manufacturing.
Correct answer is: Manufactured consistently and with proper quality control
Q.3 What is the primary purpose of the Investigational New Drug (IND) application?
To market a drug after approval
To begin human clinical trials
To manufacture drugs in bulk
To patent a new formulation
Explanation - An IND is filed to obtain regulatory approval to start testing a new drug in humans.
Correct answer is: To begin human clinical trials
Q.4 Which of the following is NOT a key component of the FDA’s Biologics License Application (BLA) process?
Preclinical data
Phase I clinical trial results
Manufacturing site inspection
Marketing strategy
Explanation - The BLA focuses on safety, efficacy, and manufacturing; marketing plans are not part of the regulatory review.
Correct answer is: Marketing strategy
Q.5 Ethical considerations in gene therapy trials must address all of the following EXCEPT:
Long‑term safety monitoring
Patient informed consent
Genetic discrimination by insurers
Immediate therapeutic benefit to the trial sponsor
Explanation - Ethics focus on patient welfare, not the sponsor’s direct benefit; sponsor gain is not an ethical concern.
Correct answer is: Immediate therapeutic benefit to the trial sponsor
Q.6 What does the term “biological equivalence” refer to in biosimilar approval?
Same molecular weight as the originator
Same clinical efficacy and safety profile
Identical manufacturing process
Same patent status
Explanation - Biological equivalence requires that the biosimilar performs similarly to the original biologic in terms of efficacy and safety.
Correct answer is: Same clinical efficacy and safety profile
Q.7 The 'Orphan Drug Act' provides incentives for developing therapies for:
Common diseases affecting >50% of the population
Rare diseases with limited patient populations
Medical devices only
Over-the-counter supplements
Explanation - The Act offers benefits like tax credits and market exclusivity for drugs targeting rare diseases.
Correct answer is: Rare diseases with limited patient populations
Q.8 Which ethical principle mandates that a researcher must have a favorable risk/benefit ratio in a clinical trial?
Justice
Beneficence
Autonomy
Non‑maleficence
Explanation - Beneficence requires maximizing potential benefits while minimizing harms to participants.
Correct answer is: Beneficence
Q.9 In the context of biopharmaceuticals, the term 'pharmacovigilance' refers to:
The process of drug design
Continuous monitoring of drug safety post‑marketing
A type of clinical trial phase
A regulatory approval pathway
Explanation - Pharmacovigilance tracks adverse events after a drug enters the market to ensure ongoing safety.
Correct answer is: Continuous monitoring of drug safety post‑marketing
Q.10 Which of the following is a key requirement for a biopharmaceutical’s labeling?
The cost of production
Detailed manufacturing process steps
Patient information and dosage instructions
Company logo only
Explanation - Labels must provide essential clinical information to ensure correct and safe use by patients.
Correct answer is: Patient information and dosage instructions
Q.11 A biopharmaceutical that is genetically engineered to produce a therapeutic protein in a host organism must comply with:
The International Code of Conduct for Biotechnology
The Gene Patent Act of 1995
The Genetic and Recombinant DNA Safety Act (Gordian Act)
The Clean Air Act
Explanation - The Gordian Act regulates the use of genetically engineered organisms for drug production.
Correct answer is: The Genetic and Recombinant DNA Safety Act (Gordian Act)
Q.12 In a double‑blind clinical trial, the participants and investigators:
Know which treatment each participant receives
Do not know the treatment allocation
Only the investigators are blind
Only the participants are blind
Explanation - Double‑blind ensures both participants and investigators are unaware of who receives the active drug or placebo.
Correct answer is: Do not know the treatment allocation
Q.13 What does the term 'indemnity clause' refer to in a clinical trial contract?
The trial site’s liability for product defects
The sponsor’s obligation to compensate for adverse events
The participant’s right to compensation
A clause that limits all financial responsibilities
Explanation - An indemnity clause protects the trial site and investigators from liability arising from adverse events.
Correct answer is: The sponsor’s obligation to compensate for adverse events
Q.14 Which of the following best describes 'informed consent' in the context of biopharmaceutical trials?
A legal document signed by a guardian
A brief oral explanation given at the end of the trial
A comprehensive, voluntary agreement after understanding all risks
An automatic consent granted by the regulatory agency
Explanation - Informed consent ensures participants voluntarily accept participation after being fully informed of the risks and benefits.
Correct answer is: A comprehensive, voluntary agreement after understanding all risks
Q.15 Which international guideline provides a framework for the ethical conduct of research involving human subjects?
The Declaration of Helsinki
The Nuremberg Code
The Belmont Report
All of the above
Explanation - All listed documents outline ethical principles for human subject research.
Correct answer is: All of the above
Q.16 Which of the following is NOT typically part of a biopharmaceutical’s Quality Control (QC) program?
Purity testing of the final product
Stability studies under various conditions
Assessment of the manufacturing facility’s location
Batch release testing
Explanation - QC focuses on product quality, not the geographic location of the manufacturing site.
Correct answer is: Assessment of the manufacturing facility’s location
Q.17 The 'cure' versus 'treat' distinction in biopharma regulation primarily influences:
The type of clinical trial phase
The cost of the product
The labeling and risk‑benefit assessment
The method of drug delivery
Explanation - Cure‑type therapies may be allowed higher risks due to the potential for a definitive cure, while treatments often require a better risk‑benefit ratio.
Correct answer is: The labeling and risk‑benefit assessment
Q.18 Which regulatory body is responsible for approving vaccines in the European Union?
European Medicines Agency (EMA)
FDA
WHO
FDA European Office
Explanation - EMA reviews and approves medicinal products, including vaccines, for all EU member states.
Correct answer is: European Medicines Agency (EMA)
Q.19 Which of the following is a potential ethical issue arising from biopharmaceutical pricing strategies?
Over‑protection of intellectual property
Limited patient access due to high costs
Excessive transparency in drug development
All of the above
Explanation - High pricing can restrict patient access, raising ethical concerns about equity and affordability.
Correct answer is: Limited patient access due to high costs
Q.20 In the context of a biopharmaceutical company, 'post‑marketing surveillance' involves:
Testing the drug before clinical trials
Monitoring adverse events after drug approval
Developing new drugs from scratch
Marketing the drug to physicians
Explanation - Post‑marketing surveillance tracks drug safety and efficacy in a larger, real‑world population.
Correct answer is: Monitoring adverse events after drug approval
Q.21 Which type of study is required to demonstrate the safety profile of a new biopharmaceutical before it can be tested in humans?
Phase III clinical trial
Non‑clinical (animal) study
In vitro cell culture study
Market analysis
Explanation - Non‑clinical studies assess toxicity, pharmacokinetics, and safety in animal models before human trials.
Correct answer is: Non‑clinical (animal) study
Q.22 Which of the following is a major challenge when manufacturing biologics compared to small‑molecule drugs?
They have a longer shelf life
They are easier to scale up
They require living cells or organisms
They are chemically synthesized
Explanation - Biologics often rely on cell cultures or recombinant systems, adding complexity to production.
Correct answer is: They require living cells or organisms
Q.23 The 'principle of justice' in biomedical ethics emphasizes:
That research must be beneficial to all
That participants are treated equally
That no harm should come to participants
That research must be profitable
Explanation - Justice requires equitable selection of participants and fair distribution of research benefits.
Correct answer is: That participants are treated equally
Q.24 What does the abbreviation 'CRO' stand for in the biopharmaceutical industry?
Clinical Research Organization
Critical Release Operation
Cellular Regulatory Office
Clinical Review Office
Explanation - CROs are external companies that conduct clinical trials on behalf of biopharma sponsors.
Correct answer is: Clinical Research Organization
Q.25 Which of the following best describes a 'safety pharmacology' study?
A study to confirm efficacy in humans
A study to investigate toxicities in animals
A study to assess drug interactions with the central nervous system, cardiovascular, and respiratory systems
A marketing feasibility analysis
Explanation - Safety pharmacology evaluates potential adverse effects on major physiological systems.
Correct answer is: A study to assess drug interactions with the central nervous system, cardiovascular, and respiratory systems
Q.26 Which of the following is an example of an 'off‑label' use of a biopharmaceutical?
Using a drug for its approved indication
Using a drug outside the approved age group
Using a drug in a dose exactly as approved
Using a drug only after FDA approval
Explanation - Off‑label use refers to prescribing a drug for indications, dosages, or patient populations not approved by regulators.
Correct answer is: Using a drug outside the approved age group
Q.27 The '4‑hour rule' in vaccine manufacturing ensures:
The vaccine must be administered within 4 hours of production
The manufacturing facility operates only 4 hours a day
The vaccine is stored at 4 °C
The vaccine must be released within 4 hours of final testing
Explanation - Vaccines are typically stored in a refrigerator at around 4 °C to maintain potency.
Correct answer is: The vaccine is stored at 4 °C
Q.28 In the context of clinical trial ethics, the term 'vulnerable population' refers to:
Participants who are at risk of financial loss
Participants who cannot legally consent, e.g., minors or cognitively impaired
Participants with low risk of adverse events
Participants with high drug metabolism
Explanation - Vulnerable populations require additional protections to ensure ethical participation.
Correct answer is: Participants who cannot legally consent, e.g., minors or cognitively impaired
Q.29 Which of the following best defines the term 'pharmacogenomics'?
Study of drug pricing strategies
Study of genetic factors influencing drug response
Analysis of drug side‑effects
Survey of consumer preferences for drugs
Explanation - Pharmacogenomics investigates how genetic variations affect individual responses to drugs.
Correct answer is: Study of genetic factors influencing drug response
Q.30 The primary goal of a 'Phase II' clinical trial is to:
Assess safety in a large population
Determine optimal dosage and efficacy
Confirm manufacturing scale
Gather post‑marketing safety data
Explanation - Phase II trials focus on dose‑finding and preliminary efficacy in a moderate sample size.
Correct answer is: Determine optimal dosage and efficacy
Q.31 Which of these statements is true regarding 'confidentiality' in clinical trials?
All participant data must be made public after the study
Only the sponsor can see the data, not the investigators
Personal information must be protected from unauthorized disclosure
Data can be shared freely with any third party
Explanation - Confidentiality protects participant privacy and ensures compliance with regulations such as HIPAA.
Correct answer is: Personal information must be protected from unauthorized disclosure
Q.32 Which act requires that companies disclose potential conflicts of interest in biopharmaceutical research?
The Hatch‑Waxman Act
The Federal Disclosure Act
The Truth in Research Act
The Conflict of Interest Disclosure Act
Explanation - This act mandates transparent disclosure of relationships that could bias research outcomes.
Correct answer is: The Conflict of Interest Disclosure Act
Q.33 What is the role of the 'Independent Ethics Committee' in clinical trials?
To approve marketing strategies
To monitor safety and ethical conduct of the study
To oversee financial audits
To manage manufacturing facilities
Explanation - The committee ensures participant welfare, informed consent, and adherence to ethical standards.
Correct answer is: To monitor safety and ethical conduct of the study
Q.34 Which of the following is a common form of data integrity violation?
Properly storing raw data
Adding missing data points to fit a hypothesis
Back‑dating laboratory test results
All of the above
Explanation - Data integrity requires accurate, authentic, and traceable data; any alteration is a violation.
Correct answer is: All of the above
Q.35 The term 'therapeutic misconception' refers to:
A patient’s belief that the trial is designed for their personal benefit, not research
A misunderstanding of the drug’s therapeutic mechanism
The misconception that therapy is always curative
An error in therapeutic dosage calculations
Explanation - Therapeutic misconception can undermine informed consent and ethical trial conduct.
Correct answer is: A patient’s belief that the trial is designed for their personal benefit, not research
Q.36 Which of the following best describes 'regulatory science'?
The process of creating laws for pharmaceuticals
The study of the scientific basis of regulatory decisions
A branch of law dealing with patent disputes
A statistical method for analyzing clinical trial data
Explanation - Regulatory science applies scientific methods to improve regulatory decision-making.
Correct answer is: The study of the scientific basis of regulatory decisions
Q.37 What does the abbreviation 'CMC' refer to in drug development?
Chemistry, Manufacturing and Controls
Clinical Manufacturing Committee
Common Market Code
Chemical Management Certificate
Explanation - CMC details the drug’s chemical composition, manufacturing process, and quality control.
Correct answer is: Chemistry, Manufacturing and Controls
Q.38 In a clinical trial, a 'placebo' is used to:
Provide the best treatment to all participants
Act as an active comparator for the new drug
Serve as a control to measure the drug’s effect
Guarantee participant safety
Explanation - Placebo controls help differentiate drug effects from placebo effects.
Correct answer is: Serve as a control to measure the drug’s effect
Q.39 Which type of data is considered 'clinical trial data'?
Pharmaceutical pricing data
Data from animal safety studies
Data collected from human subjects during trials
Literature review summaries
Explanation - Clinical trial data refers to information gathered from human participants during the study.
Correct answer is: Data collected from human subjects during trials
Q.40 What is a key ethical consideration when recruiting participants for a Phase I trial?
Ensuring participants receive the highest possible dose
Providing a placebo to all participants
Ensuring participants are fully aware of the investigational nature
Maximizing the speed of recruitment
Explanation - Phase I trials involve healthy volunteers; clear communication is essential for informed consent.
Correct answer is: Ensuring participants are fully aware of the investigational nature
Q.41 Which of the following is NOT a typical component of a biopharmaceutical’s ‘Quality Assurance’ (QA) system?
Process validation
Audit trails for data
Customer satisfaction surveys
Good Documentation Practices (GDP)
Explanation - QA focuses on product quality, not marketing or customer sentiment.
Correct answer is: Customer satisfaction surveys
Q.42 The 'EU Clinical Trials Regulation' (EU CTR) was enacted to:
Streamline the approval process for clinical trials in the EU
Increase the number of clinical trial sites in the EU
Standardize drug pricing across the EU
Reduce the need for ethics committees
Explanation - The EU CTR reduces administrative burdens and harmonizes requirements across member states.
Correct answer is: Streamline the approval process for clinical trials in the EU
Q.43 Which of the following best describes an 'adverse event' (AE) in clinical research?
A planned benefit from the drug
A negative outcome not related to the drug
An unintended medical occurrence during a study
A positive outcome reported in the literature
Explanation - An AE is any undesirable medical event occurring during a trial, regardless of causality.
Correct answer is: An unintended medical occurrence during a study
Q.44 In a Phase III trial, a 'randomized' study design ensures:
All participants receive the same treatment
Participants are assigned to treatment groups by chance
The sponsor chooses the best outcome for each participant
Only one arm of the study is evaluated
Explanation - Randomization reduces bias and balances baseline characteristics across groups.
Correct answer is: Participants are assigned to treatment groups by chance
Q.45 What does the abbreviation 'IRB' stand for in the context of human subjects research?
Independent Review Board
Institutional Review Board
International Research Bureau
Institutional Regulatory Bureau
Explanation - IRBs review research protocols to protect human participants.
Correct answer is: Institutional Review Board
Q.46 Which regulatory pathway allows a drug to be approved based on surrogate endpoints?
Accelerated Approval
Fast Track
Traditional Approval
Post‑Marketing Surveillance
Explanation - Accelerated approval permits drug approval based on surrogate markers that predict clinical benefit.
Correct answer is: Accelerated Approval
Q.47 A 'phase I' study primarily investigates:
Efficacy in a large population
Safety and pharmacokinetics in a small group
Long‑term safety in millions of patients
Marketing potential
Explanation - Phase I focuses on safety, tolerability, and dosage in healthy volunteers or patients.
Correct answer is: Safety and pharmacokinetics in a small group
Q.48 The '5‑step process' for biopharmaceutical product development includes:
Discovery, Pre‑clinical, Clinical, Manufacturing, Marketing
Design, Development, Deployment, Distribution, Disposal
Discovery, Design, Delivery, Demolition, Disposal
None of the above
Explanation - These steps outline the typical phases from idea to market.
Correct answer is: Discovery, Pre‑clinical, Clinical, Manufacturing, Marketing
Q.49 Which of the following is a requirement for a biopharmaceutical's labeling regarding storage?
It must include a picture of the drug
It must specify temperature range and conditions
It must be in multiple languages
It must provide the manufacturing cost
Explanation - Proper storage instructions are essential for maintaining drug efficacy and safety.
Correct answer is: It must specify temperature range and conditions
Q.50 The primary aim of a pharmacokinetic study is to determine:
The drug’s therapeutic effect in humans
The drug’s absorption, distribution, metabolism, and excretion (ADME) profile
The drug’s chemical synthesis route
The drug’s price elasticity
Explanation - Pharmacokinetics studies how the body handles a drug.
Correct answer is: The drug’s absorption, distribution, metabolism, and excretion (ADME) profile
Q.51 Which of the following is NOT a typical source of conflict of interest in biopharma research?
Financial compensation from sponsors
Personal relationships with industry personnel
Academic publication fees
Researcher's independent grant funding
Explanation - Independent grant funding generally reduces conflict; financial ties to sponsors are typical sources.
Correct answer is: Researcher's independent grant funding
Q.52 Which of the following best describes a 'single‑blind' study?
Neither participant nor investigator knows treatment
Only participants know their treatment
Only investigators know treatment
Both participants and investigators are blind
Explanation - In single‑blind trials, only the investigator is unaware of the participant’s group.
Correct answer is: Only investigators know treatment
Q.53 Which regulatory document provides detailed guidance on the use of human embryonic stem cells?
FDA Stem Cell Guidelines
International Society for Stem Cell Research (ISSCR) Guidelines
WHO Stem Cell Code of Conduct
European Stem Cell Directive
Explanation - ISSCR offers comprehensive recommendations for stem cell research and applications.
Correct answer is: International Society for Stem Cell Research (ISSCR) Guidelines
Q.54 Why is the 'placebo effect' important in clinical trials?
It guarantees all participants benefit
It can obscure the true efficacy of a treatment
It is a type of drug effect
It ensures ethical treatment of participants
Explanation - The placebo effect can produce improvements that mimic drug efficacy, affecting study outcomes.
Correct answer is: It can obscure the true efficacy of a treatment
Q.55 The 'principle of autonomy' in clinical research emphasizes:
The sponsor's right to approve the study design
The participant’s right to make informed decisions
The researcher’s right to publish results
The ethics committee’s authority to withdraw participants
Explanation - Autonomy protects participant freedom and informed choice.
Correct answer is: The participant’s right to make informed decisions
Q.56 Which of the following is a requirement for the 'IND' application before initiating clinical trials in the U.S.?
Preclinical safety data
Marketing plan
Manufacturing location details
Patient testimonials
Explanation - Preclinical safety data is essential to justify starting human trials.
Correct answer is: Preclinical safety data
Q.57 Which term refers to a drug that has undergone regulatory review in one country and is then approved for marketing in other countries based on that review?
Global drug
Centrally approved drug
Parallel approved drug
Extrapolated approval
Explanation - Parallel approval allows other markets to rely on a primary country’s assessment.
Correct answer is: Parallel approved drug
Q.58 Which of the following best defines 'clinical data integrity'?
Ensuring all data is available online
Ensuring data is accurate, complete, and traceable
Ensuring data is kept confidential
Ensuring data is stored in the most secure location
Explanation - Data integrity is about the authenticity and reliability of research data.
Correct answer is: Ensuring data is accurate, complete, and traceable
Q.59 Which of the following is a potential risk of 'off‑label' prescribing?
Improved efficacy
Increased drug cost
Unregulated safety profile
Higher patient satisfaction
Explanation - Off‑label use may lack comprehensive safety data for the new indication.
Correct answer is: Unregulated safety profile
Q.60 In a pharmacodynamic study, researchers are most interested in:
The drug’s metabolism in the liver
The drug’s effect on biological targets
The drug’s price in the market
The drug’s manufacturing process
Explanation - Pharmacodynamics examines how the drug influences biological systems.
Correct answer is: The drug’s effect on biological targets
Q.61 The '4‑s' principle in biopharmaceutical trials refers to:
Safety, Significance, Sample Size, Statistical analysis
Sustainability, Safety, Sensitivity, Speed
Sampling, Sampling, Sampling, Sampling
Safety, Secrecy, Significance, Speed
Explanation - The 4‑s framework guides key design aspects of a study.
Correct answer is: Safety, Significance, Sample Size, Statistical analysis
Q.62 Which of the following best explains the concept of 'product liability' in biopharma?
The responsibility of a manufacturer for product safety
The legal responsibility of a patient for drug use
The liability of a distributor to provide low prices
The obligation of a sponsor to report sales
Explanation - Product liability holds manufacturers accountable for unsafe or defective products.
Correct answer is: The responsibility of a manufacturer for product safety
Q.63 Which of the following is an example of a 'real‑world evidence' (RWE) data source?
Randomized controlled trial data
Electronic health record (EHR) data
Clinical trial case reports
Pre‑clinical animal study data
Explanation - RWE includes data from routine clinical practice, such as EHRs.
Correct answer is: Electronic health record (EHR) data
Q.64 In biopharmaceuticals, a 'batch release' occurs when:
The batch is sold to distributors
The batch meets quality specifications after testing
The batch is manufactured in a single production run
The batch is approved by the FDA
Explanation - Batch release requires that all QC tests confirm the product meets standards.
Correct answer is: The batch meets quality specifications after testing
Q.65 Which of these is a common ethical concern with the use of animals in biopharma research?
Lack of animal housing standards
Potential for animal suffering and unnecessary use
High cost of animal procurement
Difficulty in obtaining animal data
Explanation - Ethical guidelines mandate the 3Rs: Replacement, Reduction, Refinement.
Correct answer is: Potential for animal suffering and unnecessary use
Q.66 A 'pre‑clinical' study typically includes which of the following?
Human clinical trials
Animal toxicity studies
Marketing plan development
Post‑marketing surveillance
Explanation - Pre‑clinical testing uses animal models to assess safety before human trials.
Correct answer is: Animal toxicity studies
Q.67 Which of the following is a primary benefit of 'adaptive trial designs'?
They eliminate the need for a control group
They allow modifications based on interim data
They guarantee faster regulatory approval
They are only used in drug pricing studies
Explanation - Adaptive designs let researchers change aspects of the study as data emerges, improving efficiency.
Correct answer is: They allow modifications based on interim data
Q.68 Which of the following statements best describes 'pharmacogenomics'?
The study of drug pricing strategies
The study of how genes influence drug response
The analysis of drug side‑effects in the public
The process of marketing a drug globally
Explanation - Pharmacogenomics examines genetic factors affecting how patients respond to drugs.
Correct answer is: The study of how genes influence drug response
Q.69 In the context of regulatory approval, what is a 'Biologics License Application' (BLA)?
An application for a small molecule drug
An application for a new vaccine only
An application for a biologic product to obtain marketing authorization
An application for a medical device
Explanation - BLA is the formal FDA submission for biologic products, including biologics, vaccines, and gene therapies.
Correct answer is: An application for a biologic product to obtain marketing authorization
Q.70 Which of the following is a primary purpose of 'pharmacovigilance' activities?
To develop new drug formulations
To monitor drug safety after approval
To design clinical trials
To regulate drug pricing
Explanation - Pharmacovigilance tracks adverse events and ensures ongoing drug safety.
Correct answer is: To monitor drug safety after approval
Q.71 The term 'clinical relevance' in drug development refers to:
The drug’s cost to the patient
The drug’s statistical significance in a trial
The drug’s ability to produce meaningful health outcomes
The drug’s marketing potential
Explanation - Clinical relevance focuses on real‑world benefit to patients, not just statistical findings.
Correct answer is: The drug’s ability to produce meaningful health outcomes
Q.72 Which of the following best describes a 'sponsor' in clinical trials?
A researcher who conducts the trial
An organization or individual that initiates and funds the study
A regulatory agency
A patient volunteer
Explanation - The sponsor is responsible for the trial’s financial, logistical, and regulatory aspects.
Correct answer is: An organization or individual that initiates and funds the study
Q.73 What is the main ethical concern in using 'placebo' in trials involving life‑threatening diseases?
Placebo may be more effective than the treatment
Participants might not receive an active treatment when effective therapy exists
Placebo causes increased side‑effects
Placebo increases trial cost
Explanation - Ethical guidelines often prohibit placebo controls when proven effective therapy is available.
Correct answer is: Participants might not receive an active treatment when effective therapy exists
Q.74 The '4‑hour rule' in vaccine storage requires vaccines to be:
Stored at 4 °C
Administered within 4 hours of arrival
Produced in a facility with 4‑hour turnaround
Manufactured within 4 hours
Explanation - Vaccines need refrigeration at around 4 °C to remain stable and effective.
Correct answer is: Stored at 4 °C
Q.75 Which of the following is NOT a standard part of a clinical trial protocol?
Eligibility criteria
Randomization method
Marketing plan
Statistical analysis plan
Explanation - Clinical protocols focus on study design and procedures, not marketing.
Correct answer is: Marketing plan
Q.76 Which of the following best describes 'informed consent'?
A signed document acknowledging the study
A verbal agreement from the patient’s family
A voluntary, informed agreement after understanding all risks and benefits
An administrative form submitted to the ethics committee
Explanation - Informed consent ensures participants voluntarily accept the risks and benefits after being fully informed.
Correct answer is: A voluntary, informed agreement after understanding all risks and benefits
Q.77 Which of these is a typical content area of the 'Quality Assurance' (QA) documentation in biopharma?
Product marketing strategy
Quality Control (QC) procedures
Patient recruitment methods
Clinical trial outcomes
Explanation - QA oversees QC activities to ensure product quality.
Correct answer is: Quality Control (QC) procedures
Q.78 What does 'double‑blind' mean in a clinical trial?
Only the investigator is unaware of treatment assignment
Both participants and investigators are unaware of treatment assignment
Both participants and investigators are aware of treatment assignment
Only the participants are unaware of treatment assignment
Explanation - Double‑blind trials reduce bias by keeping both parties uninformed about assignments.
Correct answer is: Both participants and investigators are unaware of treatment assignment
Q.79 Which of the following is a key element of 'pharmacoeconomic' analysis in drug development?
Efficacy of drug in animal models
Cost–benefit analysis of the drug
Marketing strategy
Patent filing process
Explanation - Pharmacoeconomic studies evaluate economic value relative to costs.
Correct answer is: Cost–benefit analysis of the drug
Q.80 Which of the following best describes an 'open‑label' study?
Participants and investigators are both blinded
Only participants are blinded
Both participants and investigators are aware of treatment
Investigators are blinded but participants are not
Explanation - Open‑label trials have no blinding; all parties know what treatment is given.
Correct answer is: Both participants and investigators are aware of treatment
Q.81 What is the main purpose of 'post‑marketing surveillance'?
To collect marketing data
To monitor drug safety after approval in real‑world settings
To conduct Phase III trials
To approve new drugs
Explanation - Post‑marketing surveillance tracks adverse events in larger, diverse populations.
Correct answer is: To monitor drug safety after approval in real‑world settings
Q.82 Which regulatory requirement addresses the protection of patient privacy in clinical studies?
Good Manufacturing Practice (GMP)
Good Clinical Practice (GCP)
HIPAA
FDA Drug Code
Explanation - HIPAA ensures confidentiality of personal health information in the U.S.
Correct answer is: HIPAA
Q.83 Which of the following is a typical reason for 'stopping a clinical trial early'?
Significant safety concerns
Financial profitability
Lack of participant interest
All of the above
Explanation - Safety concerns, not profit or participant numbers, warrant early termination.
Correct answer is: Significant safety concerns
Q.84 Which of the following is an example of a 'safety‑pharmacology' study?
An assessment of cardiovascular risk in healthy volunteers
A price comparison of biologics
A marketing survey of patients
A genetic analysis of drug metabolism
Explanation - Safety‑pharmacology studies evaluate potential adverse effects on major organ systems.
Correct answer is: An assessment of cardiovascular risk in healthy volunteers
Q.85 Which of the following is a common ethical issue in the use of 'human embryonic stem cells'?
Lack of standard protocols
The moral status of the embryo
High manufacturing costs
Limited availability of donors
Explanation - Ethical concerns revolve around the creation and destruction of human embryos.
Correct answer is: The moral status of the embryo
Q.86 Which of the following is a key component of an 'independent data monitoring committee' (IDMC)?
Sponsor representatives
Investigators from the trial site
Independent experts who review interim data
Regulatory agency staff
Explanation - IDMCs provide unbiased oversight of safety and efficacy data.
Correct answer is: Independent experts who review interim data
Q.87 The principle of 'non‑maleficence' in biomedical research means:
The research must be beneficial to all
No harm should come to participants
Participants should receive maximum benefit
The researcher should not be harmed
Explanation - Non‑maleficence requires avoiding or minimizing harm to participants.
Correct answer is: No harm should come to participants
Q.88 What does 'pharmacokinetics' study?
How the drug acts on the body
How the body processes the drug
The drug’s chemical synthesis
The drug’s price dynamics
Explanation - Pharmacokinetics examines absorption, distribution, metabolism, and excretion.
Correct answer is: How the body processes the drug
Q.89 In the context of clinical trials, what is meant by 'intention‑to‑treat' (ITT) analysis?
Analyzing only those who completed the treatment
Analyzing all participants based on the group they were originally assigned to
Analyzing participants who tolerated the treatment
An analysis based on the dosage taken
Explanation - ITT includes all randomized subjects to avoid bias from dropouts.
Correct answer is: Analyzing all participants based on the group they were originally assigned to
Q.90 Which of the following is a requirement for a 'Biologics License Application' (BLA) under the FDA?
A detailed safety and efficacy data package
A marketing plan for the product
A patent filing submission
A pre‑clinical safety report only
Explanation - The BLA must contain comprehensive data proving safety and efficacy.
Correct answer is: A detailed safety and efficacy data package
Q.91 Which of the following is a primary function of the 'Good Clinical Practice' (GCP) guidelines?
To regulate drug pricing
To standardize clinical trial conduct and protect participants
To determine the manufacturing facility location
To provide marketing guidelines
Explanation - GCP provides ethical and scientific quality standards for human studies.
Correct answer is: To standardize clinical trial conduct and protect participants
Q.92 What is a 'pharmacovigilance system' primarily used for?
Developing new drug candidates
Monitoring adverse events post‑marketing
Regulating drug pricing
Assessing manufacturing processes
Explanation - Pharmacovigilance tracks drug safety after approval in the real world.
Correct answer is: Monitoring adverse events post‑marketing
Q.93 The '3Rs' principle in animal research stands for:
Reduce, Replace, Refine
Risk, Regulation, Review
Research, Results, Reporting
Reduce, Regenerate, Recycle
Explanation - The 3Rs aim to minimize animal use and suffering in research.
Correct answer is: Reduce, Replace, Refine
Q.94 Which of the following is a characteristic of a 'sponsor' in clinical research?
They provide the drug to patients
They conduct the trial data analysis
They initiate, fund, and oversee the trial
They review the data after the trial concludes
Explanation - The sponsor is responsible for the trial’s overall conduct and regulatory compliance.
Correct answer is: They initiate, fund, and oversee the trial
Q.95 In a 'phase II' clinical trial, the main focus is:
Confirming efficacy and safety in a large population
Determining optimal dosage and preliminary efficacy
Assessing long‑term safety in millions of patients
Developing marketing strategies
Explanation - Phase II evaluates dose ranges and efficacy in a moderate sample.
Correct answer is: Determining optimal dosage and preliminary efficacy
Q.96 The 'Harmonized Tripartite Guidelines' are intended to:
Standardize drug pricing across regions
Align safety, quality, and efficacy standards for biologics
Coordinate marketing efforts worldwide
Regulate data storage practices
Explanation - The Tripartite Guidelines involve FDA, EMA, and PMDA to harmonize biopharmaceutical regulations.
Correct answer is: Align safety, quality, and efficacy standards for biologics
Q.97 What does 'confidentiality' in clinical research require?
All data must be publicly available
Personal data must be protected from unauthorized disclosure
Only the sponsor can access the data
All trial results must be posted on the internet
Explanation - Confidentiality safeguards participant privacy and complies with data‑protection laws.
Correct answer is: Personal data must be protected from unauthorized disclosure
Q.98 The '4‑hour rule' is specific to:
Vaccines that require refrigeration at 4 °C
Clinical trials conducted in four hours
Manufacturing processes that must be completed in four hours
Data analysis deadlines
Explanation - Vaccines must be stored at ~4 °C to maintain potency.
Correct answer is: Vaccines that require refrigeration at 4 °C
Q.99 The 'principle of justice' in clinical research primarily concerns:
Ensuring equal treatment of participants
Ensuring all research results are published
Ensuring the sponsor pays fair wages
Ensuring all data are stored securely
Explanation - Justice requires fair and equitable selection and treatment of trial subjects.
Correct answer is: Ensuring equal treatment of participants
Q.100 Which of the following best defines 'post‑marketing surveillance'?
Testing the drug before clinical trials
Collecting safety data after the drug is approved
Conducting early phase clinical trials
Developing a marketing campaign
Explanation - Post‑marketing surveillance monitors adverse events in real‑world use.
Correct answer is: Collecting safety data after the drug is approved
Q.101 In the 'phase I' trial of a new biologic, what is typically evaluated?
Efficacy in a large cohort
Safety and pharmacokinetics in healthy volunteers
Long‑term safety in millions of patients
Marketing potential
Explanation - Phase I focuses on safety and drug disposition.
Correct answer is: Safety and pharmacokinetics in healthy volunteers
Q.102 Which of these is a potential ethical issue when using human embryonic stem cells?
High manufacturing cost
Moral status of the embryo
Limited availability of donors
Unclear patent status
Explanation - Ethics debates arise over destroying human embryos to harvest stem cells.
Correct answer is: Moral status of the embryo
Q.103 Which of the following is an example of a 'clinical trial endpoint'?
Number of patients recruited
Primary efficacy measure like tumor shrinkage
Cost of the drug
Marketing strategy
Explanation - Endpoints measure the main outcome of the study.
Correct answer is: Primary efficacy measure like tumor shrinkage
Q.104 What does the 'Harmonized Tripartite Guidelines' primarily aim to standardize?
Drug pricing across regions
Safety, quality, and efficacy standards for biologics
Marketing and promotional practices
Clinical trial site selection
Explanation - They promote consistency among FDA, EMA, and PMDA.
Correct answer is: Safety, quality, and efficacy standards for biologics
Q.105 Which of the following is a requirement for the 'IND' application?
Preclinical safety data
Marketing strategy
Manufacturing site location
Patient testimonials
Explanation - IND requires preclinical data to justify human testing.
Correct answer is: Preclinical safety data
Q.106 Which of these best represents 'pharmacogenomics'?
Study of drug pricing
Study of how genes influence drug response
Analysis of drug side‑effects
Development of marketing strategies
Explanation - Pharmacogenomics examines genetic factors affecting drug efficacy and safety.
Correct answer is: Study of how genes influence drug response