USP Dissolution Requirements Quiz
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Questions and Answers

What does the FDA define as equivalency?

  • Pharmaceutical equivalents or pharmaceutical alternatives with identical amounts of the same active drug ingredient, dosage forms, and meeting the same standards of identity, strength, quality, and purity (correct)
  • Pharmaceutical look-alikes with similar packaging and color but different active ingredients
  • Generic drugs with similar but not identical active drug ingredients and different dosage forms
  • Drugs produced in the same country with similar but not identical active drug ingredients
  • What factors can cause bioavailability and bioinequivalence problems?

  • Manufacturing location, packaging color, tablet shape, and preservative use
  • Drug particle size, excessive lubricant use, coating materials, and inadequate tablet or capsule disintegrants (correct)
  • Active drug ingredient source, marketing strategy, brand name, and tablet hardness
  • Drug expiration date, storage temperature, humidity, and transportation method
  • What does the USP include to help define product differences when bioinequivalence is found?

  • Dissolution requirements for capsules and tablets (correct)
  • Chemical composition guidelines for drug products
  • Manufacturing process specifications for drug packaging
  • Physical appearance standards for tablets and capsules
  • What do bioequivalent drug products have under similar experimental conditions?

    <p>Similar absorption rates and extents</p> Signup and view all the answers

    What does the rate and extent of a drug's availability for biologic absorption depend on?

    <p>The materials in the formulation and the method of manufacture</p> Signup and view all the answers

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