FDA Regulations for Drug Products
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Questions and Answers

What may the FDA require if some differences between a proposed drug product and a previously approved drug product can affect bioavailability?

  • Phase 1 clinical trials
  • Post-marketing surveillance
  • In vitro studies
  • In vivo studies (correct)

    • Which of the following is NOT a variable that can contribute to differences between drug products?

  • Color of the tablet
  • Shape of the tablet
  • Temperature during storage (correct)
  • Particle size

    • Why are bioequivalency problems more significant among tablets compared to other dosage forms?

  • Because tablets have more ingredients
  • Due to variations in the manufacturing process (correct)
  • Tablets are not stable during shipping
  • The FDA requires more stringent testing for tablets

    • What factor can vary in tablets based on the punches, dies, and compression forces used in the manufacturing process?

    <p>Hardness</p> Signup and view all the answers

    How can the integrity of tablets be altered during packaging, shipping, and storage?

    <p>All of the above</p> Signup and view all the answers

    What may affect the rates of tablet disintegration, drug dissolution, and drug absorption?

    <p>All of the above</p> Signup and view all the answers

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