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Quizzes > Quizzes for Business > Healthcare

Pharmaceutical Product and Device Knowledge Assessment Quiz

Sharpen Your Skills in Product and Device Knowledge

Difficulty: Moderate
Questions: 20
Learning OutcomesStudy Material
Colorful paper art depicting quiz on Pharmaceutical Product and Device Knowledge Assessment.

Ready to expand your understanding with a focused pharmaceutical quiz? This Pharmaceutical Product and Device Knowledge Assessment Quiz offers a comprehensive challenge for pharmacists, medical device specialists, and life science students. Participants will gain deeper insights into dosage forms, delivery systems, and regulatory compliance essentials. It's fully customizable in the editor, so adjustments are effortless. Explore similar Pharmaceutical Product Knowledge Quiz or try the Medical Device Knowledge Assessment Quiz , or browse all our quizzes.

Which of the following is an example of a solid oral dosage form?
Suspension
Tablet
Inhaler
Transdermal patch
Tablets are solid oral dosage forms. Suspensions are liquid preparations, inhalers deliver aerosols, and transdermal patches deliver drugs through the skin.
Which device is commonly used for delivering aerosolized medication to the lungs?
Syringe
Nebulizer
Transdermal patch
Intravenous infusion pump
A nebulizer converts liquid medication into a fine mist for inhalation into the lungs. It is specifically designed for aerosol delivery.
What is the primary advantage of a sustained-release oral dosage form?
Faster drug absorption
Reduced dosing frequency
Increased first-pass metabolism
Immediate therapeutic effect
Sustained-release formulations are designed to release drug slowly over time, maintaining therapeutic levels and reducing the number of daily doses.
Which device is typically used for subcutaneous insulin administration?
Metered-dose inhaler
Insulin pen
Dry powder inhaler
Intramuscular syringe
Insulin pens are designed for convenient and accurate subcutaneous dosing of insulin. They combine a cartridge and a dosing mechanism in one device.
Which route of administration is parenteral?
Oral
Topical
Intravenous
Transdermal
Parenteral administration refers to routes that bypass the gastrointestinal tract. Intravenous delivery is a classic parenteral route.
In a standard hypodermic syringe, what is the primary function of the plunger?
To filter particulates
To adjust needle length
To draw in and expel fluid
To seal the needle hub
The plunger moves within the barrel to create suction that draws fluid in or pressure that expels fluid. It is the primary fluid-handling component.
Which material is commonly used for metered-dose inhaler (MDI) canisters to minimize drug adsorption?
Polyethylene
Aluminum
Glass
Stainless steel
Aluminum canisters resist corrosion and provide a non-reactive surface, minimizing drug adsorption and maintaining dose consistency in MDIs.
What is the purpose of a luer-lock connector in drug delivery devices?
To measure dosage volume
To securely attach needles or catheters
To filter bacteria
To sterilize the fluid path
Luer-lock connectors use a threaded design to securely fasten needles or tubing, preventing accidental disconnection during administration.
An elastomeric balloon pump is best described as:
A passive transdermal patch
A device delivering constant infusion without electricity
An inhalation spacer
A manual syringe type
Elastomeric balloon pumps use the elastic recoil of a prefilled balloon reservoir to deliver a controlled infusion rate without an external power source.
Which of the following propellants is commonly used in MDIs?
Chlorofluorocarbon (CFC)
Hydrofluoroalkane (HFA)
Nitrogen gas
Carbon dioxide
Hydrofluoroalkanes (HFAs) replaced CFCs in MDIs due to environmental regulations and provide efficient aerosolization of drug formulations.
According to FDA classification, a prefilled insulin pen is considered a:
Drug-only product
Device-only product
Drug-device combination product
Biologic product
A prefilled insulin pen combines a drug formulation with an integral delivery device, and is regulated by the FDA as a combination product.
In a drug-eluting stent, the primary mode of action is classified based on:
Device component structure
Drug component pharmacology
Mechanical dilation only
Surgical implantation procedure
Although a stent provides mechanical support, a drug-eluting stent's primary therapeutic effect comes from the pharmacological action of the released drug.
For uncoated tablets, weight variation must typically fall within what limit of the average weight?
±5%
±15%
±25%
±50%
USP guidelines require that most uncoated tablets must not deviate more than ±5% from the average weight to ensure dose uniformity.
Sterility assurance level (SAL) of 10❻❶ indicates that:
Every item is sterile
One in a million items may be non-sterile
One in a thousand items is sterile
One in a million items is sterile
An SAL of 10❻❶ means there is a one in one million probability that a sterilized item is non-sterile, which is the industry standard for many parenteral products.
Extractables and leachables studies are most critical for which device component?
Metal housing only
Elastomeric stopper in a vial
External plastic packaging
Glass syringe barrel surface
Elastomeric stoppers are in direct contact with drug formulations and can leach additives. Studying extractables and leachables ensures product safety and compatibility.
When designing a sustained-release matrix tablet, which polymer is most appropriate for forming a hydrophobic matrix?
Hydroxypropyl methylcellulose (HPMC)
Ethylcellulose
Polyvinylpyrrolidone
Sodium carboxymethylcellulose
Ethylcellulose is a water-insoluble, hydrophobic polymer used to form a matrix that slows drug release primarily by diffusion through the polymer network.
Selecting an appropriate needle gauge for pediatric subcutaneous injections, which gauge is thinnest and minimizes pain?
18G
21G
25G
14G
Higher gauge numbers correspond to thinner needles. A 25G needle is thin enough to minimize pain while still providing reliable subcutaneous delivery.
Which analytical technique is most suitable for assessing the particle size distribution in a dry powder inhaler (DPI)?
High-performance liquid chromatography
Cascade impactor analysis
UV-Vis spectrophotometry
Karl Fischer titration
Cascade impactors separate aerosol particles by aerodynamic diameter across stages, providing a direct measure of DPI particle size distribution.
Under ISO 10993-5, which test is used to evaluate cytotoxicity of materials in contact with parenteral drugs?
Guinea pig maximization test
MEM elution assay
Irritation test in rabbits
In vivo implantation study only
The MEM elution assay is a standard in vitro cytotoxicity test under ISO 10993-5, assessing whether materials release toxic substances that kill cultured cells.
In validating a sterilization process for a drug-device combination, the media-fill test is primarily used to:
Assess chemical purity of device materials
Demonstrate aseptic processing under worst-case conditions
Measure residual solvents after sterilization
Evaluate mechanical strength of container closure
Media-fill tests simulate the aseptic filling process using growth media in place of product. They verify that the process does not introduce microbial contamination under worst-case conditions.
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Learning Outcomes

  1. Identify common pharmaceutical dosage forms and device delivery methods.
  2. Analyse device components for safe and effective administration.
  3. Apply regulatory guidelines to drug-device combination products.
  4. Evaluate quality control parameters for pharmaceuticals and devices.
  5. Demonstrate understanding of formulation principles and device mechanisms.

Cheat Sheet

  1. Mix 'n' Match Dosage Forms - Think of tablets, capsules, and injectables as puzzle pieces that need the right delivery device to work. Understanding how syringes, inhalers, and pens snap together with drugs is key to making treatments effective and safe. Ready to dive deeper? About Combination Products | FDA
  2. Peek Inside Delivery Devices - Ever wondered how that inhaler actually dispenses medicine or what makes a syringe tick? Analyzing the inner workings of these gadgets helps you spot potential errors and keep patients safe. Gear up for a mechanical adventure! Combination Products Guidance Documents | FDA
  3. Nail the Rules & Regulations - Navigating the FDA's rulebook can feel like a treasure hunt, but it's crucial for compliance and safety. Learn the ins and outs of premarket pathways so your combination product sails through approvals. X marks the spot! Principles of Premarket Pathways for Combination Products | FDA
  4. Quality Control Quest - From stability tests to performance checks, quality control ensures every batch meets the gold standard. Master these parameters to guarantee your products are consistent and effective. It's like being the guardian of good medicine! Current Good Manufacturing Practice Requirements for Combination Products | FDA
  5. Formulation & Device Synergy - The perfect marriage of drug chemistry and device design can turn a good therapy into a great one. Grasp how formulations and mechanisms work together to boost delivery and outcomes. Science and engineering - best friends forever! Technical Considerations for Pen, Jet, and Related Injectors | FDA
  6. Human Factors Heroics - Designing for real users means understanding human quirks and tendencies. Apply human factors engineering to minimize errors and maximize usability. After all, happy patients are safe patients! Application of Human Factors Engineering Principles | FDA
  7. Postmarketing Safety Patrol - The journey doesn't end at approval - monitoring performance after launch catches issues early. Know the reporting requirements to keep your combination product in tip-top shape. Eyes on the prize: patient well-being! Postmarketing Safety Reporting for Combination Products | FDA
  8. Classify Like a Pro - Drugs, devices, or both? Correct classification steers you down the right regulatory path. Get the lowdown on jurisdictional assignments to avoid detours. Smooth sailing ahead! Classification of Products as Drugs and Devices | FDA
  9. Premarket Pathway Playbook - Mapping your route through FDA pathways takes strategy and savvy. Explore the principles that guide premarket submissions and stay one step ahead. Game on for innovation! Premarket Pathways for Combination Products | FDA
  10. Stay Current & Connected - Regulatory guidance evolves, and so should your knowledge. Bookmark the FDA's combination products guidance page to catch updates and fresh insights. Knowledge is power! Combination Products Guidance Documents | FDA
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