Q.1 What is the primary advantage of using micro‑electromechanical systems (MEMS) in drug delivery devices?
High mechanical flexibility for wearable sensors
Low power consumption for implantable pumps
Large scale production at low cost
Enhanced optical transparency
Explanation - MEMS technology enables miniaturized, low‑power pumps that can be powered by small batteries or energy harvesters, which is critical for long‑term implantable drug delivery.
Correct answer is: Low power consumption for implantable pumps
Q.2 Which regulatory body primarily oversees clinical trials for new drug delivery devices in the United States?
Food and Drug Administration (FDA)
European Medicines Agency (EMA)
National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)
Explanation - In the U.S., the FDA regulates medical devices, including drug delivery systems, and approves their clinical testing and market release.
Correct answer is: Food and Drug Administration (FDA)
Q.3 Which of the following is NOT a typical component of an implantable drug delivery system?
Reservoir containing the active pharmaceutical ingredient
Micro‑controller to regulate release
Wireless power transmitter
Large external battery pack
Explanation - Implantable systems rely on internal, miniaturized power sources; a large external battery would defeat the purpose of being implantable.
Correct answer is: Large external battery pack
Q.4 What trend is expected to most influence future drug delivery systems over the next decade?
Increased use of bulk manufacturing
Rise of AI‑driven personalized dosing algorithms
Shift toward single‑dose tablets
Reduction in regulatory oversight
Explanation - Artificial intelligence will enable real‑time monitoring and adjustment of drug dosage based on patient data, making drug delivery more precise.
Correct answer is: Rise of AI‑driven personalized dosing algorithms
Q.5 Which material is commonly used for biodegradable microneedles in transdermal drug delivery?
Silicon
Polylactic acid (PLA)
Titanium
Polyethylene terephthalate (PET)
Explanation - PLA is biocompatible and degrades into lactic acid, making it suitable for microneedles that dissolve after inserting into skin.
Correct answer is: Polylactic acid (PLA)
Q.6 In the context of drug delivery, what does the term 'controlled release' refer to?
Releasing the drug only at the time of surgery
Releasing the drug in a predetermined, sustained manner over time
Releasing the drug in response to a specific external trigger only
Releasing the drug as a single bolus dose
Explanation - Controlled release aims to maintain therapeutic drug levels by releasing the drug at a controlled rate over an extended period.
Correct answer is: Releasing the drug in a predetermined, sustained manner over time
Q.7 Which of the following is a key challenge when designing nanocarriers for drug delivery?
Achieving high electrical conductivity
Ensuring biodegradability in the bloodstream
Manufacturing at large scale without cost
Providing optical transparency for imaging
Explanation - Nanocarriers must be biocompatible and biodegradable to avoid accumulation and potential toxicity in the body.
Correct answer is: Ensuring biodegradability in the bloodstream
Q.8 What role does the International Conference on Drug Delivery Systems (ICDS) play in the field?
Setting global safety regulations for drugs
Providing a platform for researchers to share findings
Manufacturing drug delivery devices
Funding pharmaceutical companies
Explanation - ICDS is a scientific conference where experts discuss advances and challenges in drug delivery technologies.
Correct answer is: Providing a platform for researchers to share findings
Q.9 Which of the following best describes 'smart pumps' in drug delivery?
Pumps that automatically shut off if overfilled
Pumps that can be programmed to deliver variable rates
Pumps that use mechanical timers only
Pumps that are powered by solar energy
Explanation - Smart pumps integrate microcontrollers to adjust infusion rates based on real‑time patient data or pre‑set protocols.
Correct answer is: Pumps that can be programmed to deliver variable rates
Q.10 What is the primary purpose of a 'dose‑band' in implantable drug delivery?
To limit drug leakage into surrounding tissues
To regulate the total amount of drug released over time
To protect the device from corrosion
To allow the device to be re‑charged wirelessly
Explanation - A dose‑band ensures that only a predetermined quantity of drug is released during the device’s operational life.
Correct answer is: To regulate the total amount of drug released over time
Q.11 Which emerging technology is being explored to remotely adjust drug release rates in implantable devices?
Acoustic energy
Magnetic resonance
Near‑infrared light
Ultrasound
Explanation - Near‑infrared light can penetrate skin and is used to trigger drug release in light‑responsive materials.
Correct answer is: Near‑infrared light
Q.12 What is a 'closed‑loop' drug delivery system?
A system that operates without external power
A system that adjusts drug release based on continuous feedback
A system that delivers drug to multiple organs simultaneously
A system that can be opened for maintenance
Explanation - Closed‑loop systems use sensors to monitor drug levels or physiological signals and adjust dosing in real time.
Correct answer is: A system that adjusts drug release based on continuous feedback
Q.13 Which of the following is NOT a typical FDA clearance pathway for drug delivery devices?
510(k) premarket notification
De Novo classification
Pre‑market approval (PMA)
European Union CE marking
Explanation - CE marking is a European requirement; FDA pathways are 510(k), De Novo, and PMA.
Correct answer is: European Union CE marking
Q.14 What does 'bioresorbable' mean when referring to drug delivery polymers?
They can be dissolved by external solvent
They can be absorbed by the body and eliminated without residue
They resist degradation in body fluids
They are recyclable in industrial processes
Explanation - Bioresorbable polymers degrade into harmless metabolites that the body can process or excrete.
Correct answer is: They can be absorbed by the body and eliminated without residue
Q.15 Which type of stimulus is commonly used in stimuli‑responsive drug delivery systems?
Electric voltage
Magnetic fields
Temperature changes
All of the above
Explanation - Stimuli such as electrical, magnetic, and thermal cues can trigger drug release from responsive carriers.
Correct answer is: All of the above
Q.16 What is the main advantage of using hydrogel matrices for drug delivery?
High electrical conductivity
Controlled swelling and drug release
Large mechanical strength
Chemical resistance to all solvents
Explanation - Hydrogels can swell in response to stimuli, allowing gradual release of encapsulated drugs.
Correct answer is: Controlled swelling and drug release
Q.17 Which of the following is a major regulatory consideration for nanomedicine?
Nanoparticle size distribution uniformity
Color of the product packaging
Manufacturing location only
Number of production workers
Explanation - Size uniformity affects safety, efficacy, and biodistribution, so regulators scrutinize it closely.
Correct answer is: Nanoparticle size distribution uniformity
Q.18 What does GxP stand for in the context of drug delivery system manufacturing?
General product
Good production practices
Good quality practices
Good manufacturing practices
Explanation - GxP refers to regulations that ensure quality and compliance during manufacturing of medical devices and pharmaceuticals.
Correct answer is: Good manufacturing practices
Q.19 In implantable drug delivery, which component is primarily responsible for power supply?
Solar panel
Lithium‑ion battery
Fuel cell
Piezoelectric harvester
Explanation - Lithium‑ion batteries are the most common power source for small implantable devices due to their high energy density.
Correct answer is: Lithium‑ion battery
Q.20 Which field of engineering is most closely linked with the design of microfluidic drug delivery devices?
Mechanical engineering
Electrical engineering
Civil engineering
Chemical engineering
Explanation - Electrical engineers design the control electronics and sensors for microfluidic devices, while mechanical and chemical engineering focus on fluid dynamics and materials.
Correct answer is: Electrical engineering
Q.21 What is the main purpose of a drug delivery 'trigger'?
To start manufacturing the device
To initiate drug release at a specific time or condition
To stop the device from working
To label the drug for shipping
Explanation - A trigger (e.g., light, pH, temperature) activates the release mechanism to deliver the drug when needed.
Correct answer is: To initiate drug release at a specific time or condition
Q.22 Which of the following is NOT a typical advantage of implantable drug delivery systems over oral administration?
Steady drug plasma concentration
Reduced first‑pass metabolism
Improved patient compliance
High pill burden
Explanation - Implantable devices reduce the number of pills a patient must take, not increase it.
Correct answer is: High pill burden
Q.23 In the context of drug delivery, what does the term 'pharmacokinetics' refer to?
The study of drug metabolism and excretion
The chemical structure of drugs
The economic cost of drug production
The design of drug delivery devices
Explanation - Pharmacokinetics describes how a drug moves through absorption, distribution, metabolism, and excretion in the body.
Correct answer is: The study of drug metabolism and excretion
Q.24 Which of the following is a key feature of a 'smart implant' in drug delivery?
Manual dose adjustment only
Wireless communication with a monitoring device
Fixed drug release rate
Large physical size
Explanation - Smart implants can send data and receive commands wirelessly to adjust dosing in real time.
Correct answer is: Wireless communication with a monitoring device
Q.25 What is the purpose of the 'biomimetic' approach in drug delivery systems?
To mimic the appearance of natural tissues
To replicate biological processes for improved efficacy
To reduce manufacturing costs
To avoid regulatory approval
Explanation - Biomimetic designs use natural mechanisms (e.g., cell‑penetrating peptides) to enhance drug uptake and targeting.
Correct answer is: To replicate biological processes for improved efficacy
Q.26 Which of the following materials is commonly used as a coating for drug‑eluting stents?
Polyethylene glycol (PEG)
Poly(lactic-co-glycolic acid) (PLGA)
Copper
Polystyrene
Explanation - PLGA is a biodegradable polymer that slowly releases drugs from stents, preventing restenosis.
Correct answer is: Poly(lactic-co-glycolic acid) (PLGA)
Q.27 What does the term 'pharmacometrics' encompass?
Quantitative modeling of drug effects and dosing
Analysis of drug side effects only
Measurement of drug potency
Chemical synthesis pathways
Explanation - Pharmacometrics uses mathematical models to predict how drugs behave in populations, guiding dosage recommendations.
Correct answer is: Quantitative modeling of drug effects and dosing
Q.28 Which component is critical for ensuring sterility in implantable drug delivery devices?
Coated plastic housing
Sterilization pouch
Color‑coded labeling
Water‑based lubricant
Explanation - Sterilization pouches maintain a sterile environment during storage and before implantation.
Correct answer is: Sterilization pouch
Q.29 What is the main regulatory concern for wireless communication in implantable devices?
Device size
Signal strength interference with other medical devices
Color of the device
Battery capacity
Explanation - Regulators require that wireless modules do not interfere with essential medical equipment and maintain patient safety.
Correct answer is: Signal strength interference with other medical devices
Q.30 Which of the following best describes a 'nanoparticle‑based drug delivery system'?
Large mechanical pumps
Microporous membranes
Spherical carriers on the nanometer scale
Macroscopic stents
Explanation - Nanoparticles are typically spherical or rod‑shaped particles in the 1–100 nm range that carry drugs into cells.
Correct answer is: Spherical carriers on the nanometer scale
Q.31 In drug delivery, what does the acronym 'ELISA' stand for?
Enzyme‑Linked Immunosorbent Assay
Electro‑Light Imager System Analyzer
Electronic Labeling and In‑Situ Analysis
Ethanol‑Liquid Integrated Sample Analyzer
Explanation - ELISA is a laboratory technique used to measure drug concentration in biological fluids.
Correct answer is: Enzyme‑Linked Immunosorbent Assay
Q.32 Which trend is expected to reduce the environmental impact of drug delivery device manufacturing?
Increased use of single‑use plastics
Adoption of green chemistry principles
More complex assembly lines
Higher energy consumption during production
Explanation - Green chemistry aims to design processes that minimize waste and hazardous substances, thereby reducing environmental footprints.
Correct answer is: Adoption of green chemistry principles
Q.33 What is the purpose of a 'biomarker' in the context of drug delivery?
To measure electrical resistance of devices
To indicate the presence of a disease or drug effect
To identify the manufacturer of the drug
To provide a color code for packaging
Explanation - Biomarkers are measurable indicators used to monitor therapeutic response or drug delivery efficacy.
Correct answer is: To indicate the presence of a disease or drug effect
Q.34 Which of these is a potential risk of implantable drug delivery devices?
Over‑exposure to sunlight
Foreign body reaction
High water usage
Low thermal resistance
Explanation - Foreign body reaction can cause inflammation or device rejection if materials are not fully biocompatible.
Correct answer is: Foreign body reaction
Q.35 What type of data is crucial for evaluating the safety of a new drug delivery device in a clinical trial?
Patient demographics only
Device telemetry and adverse event reports
Manufacturing cost reports
Social media sentiment analysis
Explanation - Telemetry provides real‑time data on device performance, while adverse event reports capture safety issues.
Correct answer is: Device telemetry and adverse event reports
Q.36 Which emerging technology can be used to monitor drug release in real time without invasive sampling?
Magnetic resonance imaging (MRI)
Capacitive sensors integrated into the device
Ultrasound imaging of blood
All of the above
Explanation - Capacitive sensors can detect changes in local ionic concentration, indicating drug release, without the need for blood draws.
Correct answer is: Capacitive sensors integrated into the device
Q.37 Which of the following is NOT a typical component of a transdermal patch?
Drug reservoir
Backing layer
Suction cup
Release layer
Explanation - Transdermal patches rely on adhesion and diffusion; suction cups are not used for this purpose.
Correct answer is: Suction cup
Q.38 What does the FDA term '510(k)' refer to?
Premarket approval process for new drugs
Premarket notification for medical devices
Post‑marketing surveillance system
Clinical trial registration system
Explanation - The 510(k) pathway requires that a new device is substantially equivalent to a predicate device already on the market.
Correct answer is: Premarket notification for medical devices
Q.39 Which material is most commonly used for flexible electronics in drug delivery devices?
Glass
Silicon carbide
Polyimide
Steel
Explanation - Polyimide provides mechanical flexibility and chemical resistance, making it suitable for bendable circuitry.
Correct answer is: Polyimide
Q.40 Which of the following best describes 'pH‑responsive' drug delivery systems?
Systems that release drug when the external temperature changes
Systems that release drug in response to changes in acidity or alkalinity
Systems that require electrical activation
Systems that release drug regardless of environment
Explanation - pH‑responsive carriers release their payload when encountering specific pH environments, such as tumor tissues.
Correct answer is: Systems that release drug in response to changes in acidity or alkalinity
Q.41 What does the term 'biocompatibility' refer to?
The ability of a device to withstand high temperatures
The compatibility of a device with the body’s biological systems
The device’s electrical compatibility with other devices
The device’s resistance to corrosion
Explanation - Biocompatibility ensures that a device does not elicit harmful immune responses when implanted.
Correct answer is: The compatibility of a device with the body’s biological systems
Q.42 Which of the following is a key consideration for the shelf‑life of drug delivery devices?
Device weight
Packaging integrity
Color of the casing
User manual length
Explanation - Maintaining an airtight, sterile, and UV‑protected package preserves drug stability and device functionality.
Correct answer is: Packaging integrity
Q.43 Which of these devices is an example of a 'closed‑loop' insulin delivery system?
Glucose meter
Continuous glucose monitor (CGM) with insulin pump
Manual insulin vial
Traditional insulin pen
Explanation - A CGM measures glucose levels and triggers the pump to deliver insulin automatically, creating a closed‑loop.
Correct answer is: Continuous glucose monitor (CGM) with insulin pump
Q.44 What is the primary goal of the 'biopharmaceutical classification system' (BCS) for drug delivery?
To classify drugs based on their color
To predict drug absorption and dissolution characteristics
To determine the cost of drug development
To regulate device packaging
Explanation - BCS classifies drugs into four categories based on solubility and permeability, guiding formulation strategies.
Correct answer is: To predict drug absorption and dissolution characteristics
Q.45 Which technology is commonly used to monitor drug concentration in the bloodstream non‑invasively?
Optical biosensors
Invasive blood draws
X‑ray imaging
CT scans
Explanation - Optical biosensors can detect specific drug molecules in interstitial fluid, providing near‑real‑time data.
Correct answer is: Optical biosensors
Q.46 Which of the following is a critical factor in designing a drug release profile for a chronotherapeutic drug?
Daily light exposure
Patient's circadian rhythm
Device color
Manufacturing batch size
Explanation - Chronotherapy aligns drug release with the body’s circadian cycle to maximize therapeutic benefit.
Correct answer is: Patient's circadian rhythm
Q.47 What is the purpose of a 'safety valve' in a drug delivery device?
To allow air to escape during sterilization
To prevent over‑pressure buildup and potential leakage
To ensure the device does not over‑cool
To release the drug during a power outage
Explanation - A safety valve protects the device from pressure spikes that could rupture the reservoir.
Correct answer is: To prevent over‑pressure buildup and potential leakage
Q.48 Which type of drug delivery system is most likely to use a 'pump‑free' mechanism?
Gravity‑driven infusion
Electrical‑stimulated micro‑injector
Syringe‑based needle
Battery‑powered drug cartridge
Explanation - Gravity infusion relies on the height difference between reservoir and target tissue, eliminating the need for a pump.
Correct answer is: Gravity‑driven infusion
Q.49 In regulatory submissions, which document is essential for demonstrating the safety of a new drug delivery device?
Clinical trial protocol
Environmental impact assessment
Manufacturing quality plan
All of the above
Explanation - Safety demonstration requires data from clinical trials, environmental assessments, and manufacturing quality control.
Correct answer is: All of the above
Q.50 Which of the following best describes a 'nanocarrier‑enhanced' drug delivery system?
A system that uses microneedles to deliver drugs
A system that incorporates nanoparticles to improve drug targeting
A system that uses large pumps
A system that relies on manual injection
Explanation - Nanocarriers can be engineered to target specific tissues, improving drug concentration at the site of action.
Correct answer is: A system that incorporates nanoparticles to improve drug targeting
Q.51 Which of the following is a key advantage of using an 'electroosmotic pump' in drug delivery?
It requires high mechanical power
It can generate drug gradients
It uses an electric field to move fluid
It is only applicable for external use
Explanation - Electroosmotic pumps drive fluid flow by applying an electric potential across a charged membrane.
Correct answer is: It uses an electric field to move fluid
Q.52 Which of the following is a primary goal of drug delivery device miniaturization?
Increased manufacturing cost
Reduced patient comfort
Lowered power consumption
More complex design
Explanation - Smaller devices typically consume less energy, allowing for longer operation and less invasive implantation.
Correct answer is: Lowered power consumption
Q.53 What is the most common method for sterilizing implantable drug delivery devices?
Autoclaving at 121°C
Gamma radiation
Heat‑treating at 250°C
Chemical soaking in ethanol
Explanation - Gamma radiation effectively sterilizes devices without leaving residual chemicals and maintains material integrity.
Correct answer is: Gamma radiation
Q.54 Which of the following is a challenge of using electroporation in drug delivery?
Requires high voltage pulses
Limited to external application only
No effect on cell membranes
Easy to implement in all tissues
Explanation - Electroporation uses high‑voltage pulses that can damage tissue if not carefully controlled.
Correct answer is: Requires high voltage pulses
Q.55 What is the main function of the 'control algorithm' in a programmable drug delivery pump?
To adjust infusion rates based on sensor data
To change the color of the pump
To sterilize the device
To physically move the pump
Explanation - The control algorithm interprets sensor inputs and modulates the pump’s output to meet dosing requirements.
Correct answer is: To adjust infusion rates based on sensor data
Q.56 Which of these is a potential application for micro‑electrodes in drug delivery?
Measuring blood pressure
Stimulating neurons to trigger drug release
Filtering water
Cooling the device
Explanation - Micro‑electrodes can deliver electrical stimulation to neural tissue, inducing drug release via electro‑responsive carriers.
Correct answer is: Stimulating neurons to trigger drug release
Q.57 In the development of drug delivery devices, what is 'clinical pharmacokinetic modeling' used for?
Predicting the cost of clinical trials
Optimizing dosing regimens and device design
Designing packaging materials
Selecting manufacturing locations
Explanation - Pharmacokinetic models help predict drug concentrations, informing device design and dosing schedules.
Correct answer is: Optimizing dosing regimens and device design
Q.58 Which of the following is a characteristic of 'stimuli‑responsive polymers' in drug delivery?
They remain inert at all times
They change properties in response to external signals
They are only used in bulk formulations
They cannot be engineered
Explanation - Stimuli‑responsive polymers can swell, contract, or dissolve when exposed to temperature, pH, or light.
Correct answer is: They change properties in response to external signals
Q.59 Which regulatory document outlines the required pre‑clinical data for a new drug delivery device?
Investigational New Drug (IND) application
Premarket notification (510(k))
Marketing Authorization Application (MAA)
Product Liability Report
Explanation - An IND must include pre‑clinical data to justify human trials of a drug or device.
Correct answer is: Investigational New Drug (IND) application
Q.60 What is a 'closed‑loop insulin delivery system' often called in the industry?
Artificial pancreas
Glucose injector
Insulin pump
Glucose monitor
Explanation - An artificial pancreas automatically adjusts insulin delivery based on glucose readings.
Correct answer is: Artificial pancreas
Q.61 Which of the following is a primary benefit of using polymer microneedles for vaccine delivery?
High mechanical strength
Reduced pain and improved patient compliance
Large device size
Needle reuse
Explanation - Microneedles create minimal skin punctures, reducing pain and improving adherence to vaccination schedules.
Correct answer is: Reduced pain and improved patient compliance
Q.62 In drug delivery, what does the term 'first‑pass metabolism' refer to?
The metabolic process in the kidneys
Metabolism by the liver before the drug reaches systemic circulation
Metabolism within the brain
Metabolism during excretion
Explanation - First‑pass metabolism reduces the amount of drug that enters the bloodstream after oral administration.
Correct answer is: Metabolism by the liver before the drug reaches systemic circulation
Q.63 Which of the following best describes a 'biodegradable implantable pump'?
A pump that can be re‑charged repeatedly
A pump that dissolves after drug delivery
A pump that requires surgical removal
A pump that operates without power
Explanation - Biodegradable pumps are designed to degrade safely after completing their drug release cycle, eliminating the need for removal.
Correct answer is: A pump that dissolves after drug delivery
Q.64 Which of the following is a key consideration for the long‑term biocompatibility of a drug delivery implant?
Mechanical flexibility
Electrical conductivity
Corrosion resistance
All of the above
Explanation - Long‑term implants must be flexible, electrically safe, and resist corrosion to avoid tissue damage.
Correct answer is: All of the above
Q.65 What is the primary advantage of using a 'micro‑dose' strategy in drug delivery?
Higher drug concentrations
Reduced risk of adverse reactions
Longer device lifetime
Easier manufacturing
Explanation - Micro‑dosing delivers smaller amounts, minimizing potential side effects while maintaining therapeutic effect.
Correct answer is: Reduced risk of adverse reactions
Q.66 Which type of device is commonly used for localized chemotherapeutic drug delivery in cancer treatment?
Transdermal patch
Intravenous line
Implantable drug reservoir
Oral capsule
Explanation - Implantable reservoirs allow precise, localized release of chemotherapeutics directly at the tumor site.
Correct answer is: Implantable drug reservoir
Q.67 In drug delivery, what does the acronym 'API' stand for?
Active Pharmaceutical Ingredient
Advanced Packaging Interface
Aqueous Phase Injection
All‑Purpose Inhaler
Explanation - API refers to the biologically active compound in a drug formulation.
Correct answer is: Active Pharmaceutical Ingredient
Q.68 Which of the following is a major challenge when scaling up production of micro‑scale drug delivery devices?
Maintaining uniformity of micro‑features
Increasing device weight
Adding more external power sources
Changing device color
Explanation - Mass production must preserve micro‑scale precision to ensure consistent drug release profiles.
Correct answer is: Maintaining uniformity of micro‑features
Q.69 Which of the following materials is widely used for creating flexible interconnects in drug delivery electronics?
Gold
Copper
Silver
Copper‑plated polyimide
Explanation - Copper‑plated polyimide offers flexibility and conductivity for thin‑film electronics.
Correct answer is: Copper‑plated polyimide
Q.70 What is the main purpose of the 'release trigger' in a drug delivery system?
To sterilize the device
To initiate drug release upon a specific signal
To power the electronics
To label the device
Explanation - The trigger mechanism activates drug release when a predetermined condition (e.g., temperature, light) is met.
Correct answer is: To initiate drug release upon a specific signal
Q.71 Which regulatory document is required for the marketing approval of a drug delivery device in the European Union?
CE Marking
FDA 510(k)
Pharmacopeia
ISO 9001
Explanation - CE marking confirms conformity with EU safety, health, and environmental requirements.
Correct answer is: CE Marking
Q.72 Which of the following best describes 'smart drug delivery'?
Devices that can sense and adjust dosing autonomously
Devices that dispense drugs on a fixed schedule
Manual injection systems
Bulk drug production units
Explanation - Smart delivery incorporates sensors, processors, and actuators to manage drug release in real time.
Correct answer is: Devices that can sense and adjust dosing autonomously
Q.73 What is the primary concern for the use of nanoparticles in drug delivery regarding the immune system?
Nanoparticles may cause hyper‑activity of T‑cells
Nanoparticles cannot be cleared from the body
Nanoparticles may be recognized and cleared by macrophages
Nanoparticles always integrate into DNA
Explanation - Macrophages can phagocytose nanoparticles, potentially reducing their therapeutic effectiveness.
Correct answer is: Nanoparticles may be recognized and cleared by macrophages
Q.74 Which of the following is a typical application of a 'bio‑inspired' drug delivery system?
Mimicking blood flow in pumps
Using synthetic polymers only
Large scale chemical reactors
Manual syringes
Explanation - Bio‑inspired designs often emulate natural circulatory patterns to improve fluid handling.
Correct answer is: Mimicking blood flow in pumps
Q.75 Which of the following is NOT a factor considered in the design of an implantable drug reservoir?
Drug diffusion rate
Device temperature
Battery life
User interface color
Explanation - Color is irrelevant to the reservoir’s functional design but may influence aesthetics.
Correct answer is: User interface color
Q.76 What does 'in vitro' testing mean in the context of drug delivery devices?
Testing in animal models
Testing in cell culture or test tubes
Testing on humans
Testing in field conditions
Explanation - In vitro studies are performed outside a living organism, e.g., in Petri dishes.
Correct answer is: Testing in cell culture or test tubes
Q.77 Which of the following is a common method for measuring drug release kinetics from a delivery device?
Spectrophotometry
X‑ray diffraction
Thermogravimetric analysis
Mass spectrometry
Explanation - Spectrophotometry allows real‑time monitoring of drug concentration in a release medium.
Correct answer is: Spectrophotometry
Q.78 What is the main advantage of 'on‑demand' drug delivery systems?
Constant drug levels
Delivery only when needed
Manual operation only
Large reservoir capacity
Explanation - On‑demand systems release drug in response to triggers, reducing waste and side effects.
Correct answer is: Delivery only when needed
Q.79 Which type of sensor is frequently integrated into implantable drug delivery devices to monitor drug concentration?
Thermocouple
pH sensor
Photodiode
Accelerometer
Explanation - pH sensors detect local acidity changes, indicating drug release or metabolism status.
Correct answer is: pH sensor
Q.80 Which of the following is an example of an 'external trigger' for drug release?
Temperature change
Mechanical pressure
Chemical pH shift
All of the above
Explanation - External triggers can include temperature, pressure, or pH changes that activate the release mechanism.
Correct answer is: All of the above
Q.81 What is the main purpose of using a 'biodegradable polymer' in a drug delivery patch?
To increase device durability
To allow the patch to degrade harmlessly after use
To provide electrical conductivity
To improve aesthetics
Explanation - Biodegradable polymers break down into harmless metabolites, eliminating removal steps.
Correct answer is: To allow the patch to degrade harmlessly after use
Q.82 Which of the following best describes a 'multi‑layered' drug delivery system?
A device with several drug reservoirs
A system where drug layers release at different rates
A system with multiple manufacturers
A device that uses only one material
Explanation - Multi‑layered systems can provide sequential or controlled release by layering materials with distinct properties.
Correct answer is: A system where drug layers release at different rates
Q.83 Which regulatory term refers to the guidelines ensuring safe use of medical devices in clinical settings?
Good Manufacturing Practice (GMP)
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
All of the above
Explanation - GCP outlines the design, conduct, and analysis of clinical studies involving devices.
Correct answer is: Good Clinical Practice (GCP)
Q.84 What is the typical material used for the flexible substrate in wearable drug delivery patches?
Silicone rubber
Polyethylene glycol
Polystyrene
Glass
Explanation - Silicone is flexible, biocompatible, and skin‑friendly, ideal for wearable patches.
Correct answer is: Silicone rubber
Q.85 Which of the following is a key benefit of using a 'magnetically actuated' drug delivery device?
Invasive implantation
High energy consumption
Remote control of drug release
Limited patient compliance
Explanation - Magnetic fields can non‑invasively actuate devices to deliver drug on demand.
Correct answer is: Remote control of drug release
Q.86 Which of these is a primary safety concern for drug delivery devices that use electrical stimulation?
Risk of overheating
Risk of chemical corrosion
Risk of mechanical failure
All of the above
Explanation - Electrical stimulation can generate heat, potentially damaging surrounding tissues.
Correct answer is: Risk of overheating
Q.87 Which of the following best explains the term 'dose‑regulation' in a drug delivery device?
Adjusting the device’s physical size
Modifying the drug’s chemical structure
Controlling the rate and amount of drug released
Changing the device’s color coding
Explanation - Dose regulation ensures therapeutic drug levels by adjusting release parameters.
Correct answer is: Controlling the rate and amount of drug released
Q.88 Which of the following is a common challenge in the sterilization of polymeric drug delivery devices?
Polymer degradation under high heat
High cost of sterilization
Requirement of large equipment
None of the above
Explanation - Polymeric materials can degrade or melt at high temperatures used in autoclaving.
Correct answer is: Polymer degradation under high heat
Q.89 Which of the following is a typical outcome measured in a pharmacodynamic study of a drug delivery system?
Patient’s heart rate
Drug concentration in the bloodstream over time
Device weight
Color of the packaging
Explanation - Pharmacodynamics assesses the drug’s effect by monitoring concentrations and responses.
Correct answer is: Drug concentration in the bloodstream over time
Q.90 What does the term 'in vivo' refer to in drug delivery research?
Testing within a living organism
Testing in a lab environment
Testing on computer simulations
Testing on dead tissue
Explanation - In vivo studies involve animal models or human subjects to evaluate device performance.
Correct answer is: Testing within a living organism
Q.91 Which of the following is a major advantage of using a 'nano‑carrier' over a conventional drug formulation?
Higher mechanical strength
Improved cellular uptake and targeted delivery
Simplified manufacturing
Lower cost
Explanation - Nanocarriers can penetrate cells and target specific tissues more effectively than bulk formulations.
Correct answer is: Improved cellular uptake and targeted delivery
Q.92 What is the purpose of a 'biocontainment' feature in an implantable drug delivery system?
To prevent the device from leaking into the body
To allow the device to be removed easily
To enhance device flexibility
To reduce manufacturing cost
Explanation - Biocontainment ensures that the drug remains within the reservoir and does not contaminate tissues.
Correct answer is: To prevent the device from leaking into the body
Q.93 Which of the following best defines 'smart' in the context of drug delivery devices?
Devices that are made of smart materials
Devices that can sense and adapt to physiological changes
Devices that are expensive
Devices that are large
Explanation - Smart devices incorporate sensing and control to modify drug release based on real‑time data.
Correct answer is: Devices that can sense and adapt to physiological changes
Q.94 Which of the following is a typical method to achieve 'controlled release' of drugs in micro‑devices?
Increasing device size
Using a release gate or valve
Manual adjustment by the user
Adding more drug to the reservoir
Explanation - Gates or valves can regulate the flow of drug, enabling precise control over release rates.
Correct answer is: Using a release gate or valve
Q.95 Which of the following is a key consideration for the design of a wireless power transfer system in an implantable drug delivery device?
Maximizing signal interference
Minimizing heating of surrounding tissues
Adding bulk to the device
Increasing device color contrast
Explanation - Wireless power transfer must avoid excessive heating that can damage nearby tissues.
Correct answer is: Minimizing heating of surrounding tissues
Q.96 In the context of drug delivery, what does 'dose‑sensing' typically involve?
Detecting the amount of drug delivered by the device
Measuring the device’s battery level
Counting the number of device actuations
Estimating the patient’s body weight
Explanation - Dose‑sensing systems monitor drug release to ensure accurate dosing.
Correct answer is: Detecting the amount of drug delivered by the device
Q.97 Which of the following is a critical parameter in evaluating the safety of a new drug delivery device?
Device size only
Biocompatibility and immune response
Color of the device
Number of manufacturing workers
Explanation - Ensuring that the device does not trigger an adverse immune response is vital for safety.
Correct answer is: Biocompatibility and immune response
Q.98 Which type of drug delivery system is commonly used for treating ocular diseases?
Intramuscular injection
Eye drop formulation
Transdermal patch
Oral capsule
Explanation - Eye drops provide localized therapy with minimal systemic exposure for ocular conditions.
Correct answer is: Eye drop formulation
Q.99 What does the term 'pharmacokinetics' study in relation to drug delivery?
Drug absorption, distribution, metabolism, and excretion
Drug safety in animals
Cost of drug production
Manufacturing processes
Explanation - Pharmacokinetics models how a drug moves through the body over time.
Correct answer is: Drug absorption, distribution, metabolism, and excretion
Q.100 Which of the following is a regulatory requirement for the packaging of drug delivery devices?
Use of hazardous materials
No labeling required
Compliance with material safety data sheets (MSDS)
Avoidance of tamper‑evident seals
Explanation - MSDS ensure that packaging materials are safe and properly labeled.
Correct answer is: Compliance with material safety data sheets (MSDS)
Q.101 Which technology is used to create precise micro‑features in drug delivery device manufacturing?
Laser ablation
Hand‑crafting
Large‑scale molding
Sewing
Explanation - Laser ablation offers high‑precision patterning for micro‑scale device features.
Correct answer is: Laser ablation
Q.102 Which of the following best describes an 'implantable insulin pump'?
A device that releases insulin orally
A device that delivers insulin subcutaneously via a catheter
A device that administers insulin intravenously only
A device that uses a patch for delivery
Explanation - Implantable insulin pumps are inserted under the skin to provide continuous insulin therapy.
Correct answer is: A device that delivers insulin subcutaneously via a catheter
Q.103 Which of the following is a primary goal of the FDA's 'De Novo' classification pathway?
To allow high‑risk devices to bypass review
To provide a new classification for low‑to‑moderate risk devices with no predicate
To accelerate drug approval
To reduce manufacturing costs
Explanation - De Novo allows devices lacking a predicate to be classified while still ensuring safety and efficacy.
Correct answer is: To provide a new classification for low‑to‑moderate risk devices with no predicate
Q.104 Which component is essential for a device to be classified as a 'biodegradable' drug delivery system?
An internal power source
A non‑biodegradable outer casing
Materials that degrade safely in the body
A permanent metal scaffold
Explanation - Biodegradable devices use materials that break down into harmless products within the body.
Correct answer is: Materials that degrade safely in the body
Q.105 What is a significant benefit of using 'wireless sensor networks' in drug delivery monitoring?
Increased device size
Reduced power consumption
Real‑time data collection without cables
Higher manufacturing costs
Explanation - Wireless sensors allow continuous monitoring of drug release or patient vitals without invasive wiring.
Correct answer is: Real‑time data collection without cables
Q.106 Which of the following best describes a 'nanoparticle drug delivery system'?
A system that uses macroscopic pumps
A system that encapsulates drugs within particles sized in the nanometer range
A system that delivers drugs via large implants
A system that relies on oral tablets only
Explanation - Nanoparticles are engineered to carry drugs and release them at target sites.
Correct answer is: A system that encapsulates drugs within particles sized in the nanometer range
Q.107 Which of the following is a key challenge in designing implantable drug delivery devices?
Ensuring sufficient mechanical rigidity
Managing the device’s thermal profile
Adding bulky external components
Reducing the number of sensors
Explanation - Heat generated by electronics must be minimized to avoid damaging surrounding tissues.
Correct answer is: Managing the device’s thermal profile
Q.108 Which of the following is an example of a 'transdermal' drug delivery method?
Intravenous injection
Eye drops
Topical patches
Sublingual tablets
Explanation - Transdermal patches release drugs through the skin into systemic circulation.
Correct answer is: Topical patches
Q.109 Which of the following is a potential risk when using high‑frequency electromagnetic fields in implantable devices?
Device overheating
Loss of device memory
Reduced drug potency
Increased device flexibility
Explanation - Electromagnetic fields can cause heating, potentially damaging tissues around the implant.
Correct answer is: Device overheating
Q.110 Which type of drug delivery system is most likely to be used in treating chronic pain conditions?
Single‑dose oral pills
Implantable drug reservoir
Eye drops
Inhalation aerosol
Explanation - Implants provide long‑term, continuous drug release for chronic pain management.
Correct answer is: Implantable drug reservoir
Q.111 What does the term 'electrochemical sensor' measure in a drug delivery system?
Temperature changes
Electrical resistance
Drug concentration via current changes
Device weight
Explanation - Electrochemical sensors detect drug molecules by measuring electrical signals related to concentration.
Correct answer is: Drug concentration via current changes
Q.112 Which of the following best describes a 'smart' drug delivery patch?
A patch that requires manual activation
A patch that monitors local physiological signals and adjusts drug release accordingly
A patch that uses a single large reservoir
A patch that can only deliver one dose
Explanation - Smart patches can sense body signals (e.g., temperature) and modulate drug release automatically.
Correct answer is: A patch that monitors local physiological signals and adjusts drug release accordingly
Q.113 Which of the following is a major regulatory consideration for implantable drug delivery devices?
Device aesthetics
Biocompatibility and sterility
Color of the device
Size of the user manual
Explanation - Regulators demand comprehensive biocompatibility and sterility data for implantable devices.
Correct answer is: Biocompatibility and sterility
Q.114 Which of the following is a benefit of 'on‑demand' drug delivery devices?
Increased drug waste
Reduced drug exposure to the body
Need for frequent refills
Large device size
Explanation - On‑demand devices release drug only when necessary, minimizing over‑exposure and side effects.
Correct answer is: Reduced drug exposure to the body
Q.115 Which of the following is a common challenge in the field of drug delivery system design?
Maintaining a high drug concentration in the reservoir
Ensuring consistent device temperature
Balancing release rate with patient safety
All of the above
Explanation - Designers must match drug release rates to therapeutic needs without causing toxicity.
Correct answer is: Balancing release rate with patient safety
Q.116 What is the main advantage of using a 'microfluidic' approach in drug delivery?
Large device footprint
Precise control of fluid flow at microscale
Higher power consumption
Complex manual operation
Explanation - Microfluidics allows accurate dosing and mixing of drugs within tiny channels.
Correct answer is: Precise control of fluid flow at microscale
Q.117 Which of the following is a key component in a 'closed‑loop' insulin delivery system?
Manual pump
Continuous glucose monitor (CGM)
Syringe
Tablet dispenser
Explanation - CGM provides real‑time glucose data, enabling automatic insulin adjustments.
Correct answer is: Continuous glucose monitor (CGM)
Q.118 Which of the following is a primary goal of using a 'nanoparticle' drug delivery system?
Increasing drug half‑life in the body
Reducing the cost of manufacturing
Providing a single large dose
Avoiding all regulatory oversight
Explanation - Nanoparticles can protect drugs from rapid degradation and clearance, extending therapeutic action.
Correct answer is: Increasing drug half‑life in the body
Q.119 Which of the following is a typical material used for drug‑eluting stents?
Polyethylene
Polylactic acid (PLA)
Polyethylene glycol (PEG)
Polyethylene terephthalate (PET)
Explanation - PLA is a biodegradable polymer commonly used to coat stents for drug release.
Correct answer is: Polylactic acid (PLA)
Q.120 Which of the following best describes the term 'controlled release'?
Release of drug in a single burst
Release of drug in a continuous, predictable manner over time
Release of drug only in response to external stimuli
Release of drug only when the device is activated manually
Explanation - Controlled release ensures steady drug concentrations rather than a rapid spike.
Correct answer is: Release of drug in a continuous, predictable manner over time
Q.121 Which regulatory document is required before a drug delivery device can be tested in humans in the United States?
Investigational New Drug (IND) application
FDA 510(k) pre‑market notification
CE mark application
ISO 13485 certification
Explanation - An IND ensures preclinical safety and efficacy before human trials commence.
Correct answer is: Investigational New Drug (IND) application
Q.122 Which of the following is a typical application for microneedle drug delivery systems?
Intravenous injections
Topical drug delivery through the skin
Oral drug delivery
Inhalation therapy
Explanation - Microneedles penetrate the skin minimally, delivering drugs into the dermal layer.
Correct answer is: Topical drug delivery through the skin
Q.123 Which of the following is NOT a component of a typical implantable drug delivery system?
Reservoir for the drug
Electro‑stimulating electrode
Large external battery
Micro‑controller
Explanation - Implantable systems require small, internal power sources; an external large battery would negate implantation.
Correct answer is: Large external battery
Q.124 What is the primary advantage of using a 'nanoparticle' in drug delivery?
Increased drug solubility and targeted delivery
Higher manufacturing cost
Simplified device design
Lower patient compliance
Explanation - Nanoparticles can improve drug solubility and enable targeted tissue delivery.
Correct answer is: Increased drug solubility and targeted delivery
Q.125 Which of the following is a key benefit of using 'smart' drug delivery systems?
Automatic adjustment of dosing based on physiological data
Manual dosage control only
Single‑dose delivery
No need for monitoring
Explanation - Smart systems adapt to real‑time signals to maintain optimal drug levels.
Correct answer is: Automatic adjustment of dosing based on physiological data
Q.126 Which type of drug delivery system is most often used for targeted chemotherapy?
Transdermal patch
Intravenous infusion
Targeted nanoparticle delivery
Oral capsule
Explanation - Nanoparticles can be engineered to deliver chemotherapeutics directly to tumor cells.
Correct answer is: Targeted nanoparticle delivery
Q.127 Which of the following is a typical method for sterilizing drug delivery implants?
Gamma irradiation
Boiling in water
Dry heat at 120°C for 30 min
Exposure to sunlight
Explanation - Gamma irradiation effectively sterilizes without leaving residual chemicals.
Correct answer is: Gamma irradiation
Q.128 What is a primary concern for the use of high‑frequency electromagnetic fields in implantable drug delivery devices?
Heat generation causing tissue damage
Improved drug delivery
Enhanced device flexibility
Reduced power consumption
Explanation - High‑frequency fields can cause heating, potentially harming surrounding tissues.
Correct answer is: Heat generation causing tissue damage
Q.129 Which of the following is a typical benefit of using microfluidic systems in drug delivery?
Large device size
Precise fluid handling at microscale
High power consumption
Manual operation only
Explanation - Microfluidics allows accurate control of drug dosage and mixing within tiny channels.
Correct answer is: Precise fluid handling at microscale
Q.130 Which of the following is NOT a typical feature of a smart drug delivery system?
Sensing and feedback control
Manual dosing only
Wireless communication
Programmable release profiles
Explanation - Smart systems rely on automated sensing and control rather than manual operation.
Correct answer is: Manual dosing only
Q.131 Which of the following is an advantage of using a 'biodegradable' drug delivery system?
Longer device lifespan
No need for surgical removal
Higher manufacturing cost
Reduced drug efficacy
Explanation - Biodegradable systems degrade in situ, eliminating the need for removal surgery.
Correct answer is: No need for surgical removal
Q.132 Which of the following best describes a 'pH‑responsive' drug delivery system?
A system that releases drug based on temperature
A system that releases drug in response to changes in acidity or alkalinity
A system that releases drug only when exposed to light
A system that releases drug regardless of environment
Explanation - pH‑responsive carriers release drugs when the local pH shifts, such as in tumor microenvironments.
Correct answer is: A system that releases drug in response to changes in acidity or alkalinity
Q.133 Which of the following is a key regulatory requirement for implantable drug delivery devices?
Color coding of the device
Biocompatibility testing
Large external battery
None of the above
Explanation - Regulators require detailed biocompatibility studies to ensure device safety inside the body.
Correct answer is: Biocompatibility testing
Q.134 Which of the following is a typical application for microneedles?
Intravenous infusion
Vaccination and subcutaneous delivery
Oral tablet
Inhalation therapy
Explanation - Microneedles can deliver vaccines and drugs into the dermis with minimal pain.
Correct answer is: Vaccination and subcutaneous delivery
Q.135 What does the term 'pharmacokinetics' refer to?
The study of drug absorption, distribution, metabolism, and excretion
The cost analysis of drug production
The physical characteristics of drug particles
The regulatory approval process
Explanation - Pharmacokinetics models how a drug moves through the body over time.
Correct answer is: The study of drug absorption, distribution, metabolism, and excretion
Q.136 Which of the following is a typical design goal for an implantable drug delivery device?
Large power consumption
Minimal invasiveness
Manual dosing only
No need for monitoring
Explanation - Designs aim to be as small and minimally invasive as possible for patient comfort.
Correct answer is: Minimal invasiveness
Q.137 Which of the following is a common challenge in the scaling up of microfluidic drug delivery systems?
Maintaining uniformity of micro‑channels
Increasing device bulk
Adding more sensors
Simplifying the process
Explanation - Uniform micro‑channels are critical for consistent drug dosing, and scaling up must preserve this uniformity.
Correct answer is: Maintaining uniformity of micro‑channels