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Questions and Answers
What does the FDA define as equivalency?
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?
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?
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?
What do bioequivalent drug products have under similar experimental conditions?
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What does the rate and extent of a drug's availability for biologic absorption depend on?
What does the rate and extent of a drug's availability for biologic absorption depend on?
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