FDA Regulations on Bioavailability and Bioequivalence
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Questions and Answers

What is the primary focus of the FDA's guidance on bioavailability and bioequivalence studies?

  • To ensure clinical efficacy of drug products
  • To evaluate the chemical composition of drug products
  • To compare the in vivo performance of different formulations (correct)
  • To assess the manufacturing process of drug products

    • What is the purpose of in vitro dissolution testing?

  • To assess the manufacturing process of drug products
  • To compare the bioavailability of different formulations
  • To evaluate the chemical composition of drug products
  • To predict the in vivo performance of solid oral dosage forms (correct)

    • What is the primary focus of the FDA's Title 21, Chapter I, Subchapter D?

  • Medical devices and equipment
  • Vaccines and biologics
  • Drugs for human use (correct)
  • Regulation of food products

    • What is the primary consideration in demonstrating biosimilarity to a reference product?

    <p>Scientific considerations</p> Signup and view all the answers

    What is the term for the ability of a drug to produce the same biological effects as a reference drug?

    <p>Therapeutic equivalence</p> Signup and view all the answers

    What is the purpose of the FDA's guidance on SUPAC-MR?

    <p>To provide guidance on the scale-up and postapproval changes of modified release solid oral dosage forms</p> Signup and view all the answers

    What is the primary focus of the FDA's guidance on changes to an approved NDA or ANDA?

    <p>To provide guidance on postapproval changes to an approved NDA or ANDA</p> Signup and view all the answers

    What is the purpose of in vitro dissolution testing?

    <p>To determine the bioavailability of a drug</p> Signup and view all the answers

    What is the purpose of the ICH guidance, Q3A?

    <p>To provide guidance on impurities in new drug products</p> Signup and view all the answers

    What is the consequence of increased competition from generic drugs in the pharmaceutical industry?

    <p>Decreased prices and returns</p> Signup and view all the answers

    What is the primary concern when a manufacturer makes changes to a drug product?

    <p>Adverse effect on the identity, strength, quality, purity, or potency of the drug product</p> Signup and view all the answers

    What is the concern regarding generic substitution of antiepileptic drugs?

    <p>Potential problems with bioequivalence</p> Signup and view all the answers

    What type of change requires the submission of a supplement and approval by the FDA prior to distribution of the drug product?

    <p>Major change</p> Signup and view all the answers

    What is the reporting requirement for a moderate change?

    <p>Supplement—Changes Being Effected in 30 Days</p> Signup and view all the answers

    What is the relevance of the CFR Part 320 in regards to drug regulation?

    <p>It outlines bioavailability and bioequivalence requirements</p> Signup and view all the answers

    What type of change has a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product?

    <p>Minor change</p> Signup and view all the answers

    How must minor changes be reported to the FDA?

    <p>Annual Report</p> Signup and view all the answers

    What is the purpose of the FDA reporting requirement for changes to an approved drug product?

    <p>To ensure the safety and effectiveness of the drug product</p> Signup and view all the answers

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