Bioequivalence and BA: Methods and Concepts
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Questions and Answers

Which of the following is NOT a method for assessing bioavailability and bioequivalence?

  • In vivo pharmacodynamic comparison
  • In vivo measurement of active moiety
  • In vivo clinical trial (correct)
  • In vitro comparison
  • What is the primary purpose of a prodrug?

  • To reduce biotransformation of the active drug
  • To decrease chemical stability of the active drug
  • To increase first pass metabolism
  • To improve solubility and bioavailability of the active drug (correct)
  • What is the purpose of in vitro dissolution testing in bioequivalence studies?

  • To assess the pharmacodynamic effect of the drug
  • To measure the plasma level of the active drug
  • To evaluate the chemical stability of the drug
  • To replace in vivo bioequivalence studies (correct)
  • Which type of drug products may require additional consideration in bioequivalence studies?

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

    What is the primary purpose of bioequivalence studies?

    <p>To assess the similarity in bioavailability of different drug products</p> Signup and view all the answers

    Which of the following is a factor that influences bioavailability?

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

    What is an advantage of extended release products?

    <p>Reduction in healthcare cost</p> Signup and view all the answers

    What is a characteristic of targeted-release drug products?

    <p>They release the drug at or near the intended physiologic site of action</p> Signup and view all the answers

    What is an example of an orally disintegrating tablet?

    <p>Dispersed in saliva and swallowed with little or no water</p> Signup and view all the answers

    What is the primary consideration for designing MR drug products for different routes of administration?

    <p>Physiochemical, PD, and PK properties of the drug and the properties of the materials used in the dosage form</p> Signup and view all the answers

    What is a characteristic of extended release drug products?

    <p>They reduce dosage frequency by at least 2-fold</p> Signup and view all the answers

    What is a disadvantage of extended release products?

    <p>Dose dumping</p> Signup and view all the answers

    Under what conditions can an in vivo BE study of one or more lower strengths of a drug product be waived?

    <p>If the drug product is in the same dosage form but different strengths and is proportionally similar in active and inactive ingredients</p> Signup and view all the answers

    What is a characteristic of enteric coated tablets?

    <p>They are time sensitive or dependent on the environment</p> Signup and view all the answers

    What is an example of a type of MR drug product that releases a discrete portion of the drug at a time later than immediately after administration?

    <p>Delayed release drug products</p> Signup and view all the answers

    How many types of MR oral drug products are described based on drug release characteristics?

    <p>20</p> Signup and view all the answers

    What is the main difference between controlled release and delayed release drug products?

    <p>Controlled release products release the drug promptly after administration, while delayed release products release a discrete portion of the drug at a time later than immediately after administration</p> Signup and view all the answers

    What is the purpose of a Positive Formulary?

    <p>To list therapeutically equivalent or interchangeable drug products that pharmacists may dispense</p> Signup and view all the answers

    What is required for a generic product to be assumed therapeutically equivalent?

    <p>It must be approved as safe and effective, be pharmaceutically equivalent, bioequivalent, adequately labeled, and manufactured in compliance with Current Good Manufacturing Practice regulations</p> Signup and view all the answers

    What is the name of a type of oral extended-release rate dosage form previously described?

    <p>Controlled release</p> Signup and view all the answers

    What does 'modified release' refer to in relation to oral drug products?

    <p>A type of oral dosage form that alters the timing and/or rate of release of the drug</p> Signup and view all the answers

    What is the purpose of an in vivo BE study?

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

    Study Notes

    Methods for Assessing BA and BE

    • In vivo measurement of active moiety or moieties in biological fluid (PK study)
    • In vivo pharmacodynamic (PD) comparison
    • In vivo limited clinical comparison
    • In vitro comparison
    • Any approach deemed acceptable by the FDA

    Factors Influencing BA

    • No details provided

    Definition of a Prodrug

    • A prodrug is a chemically modified drug, usually an inactive form, to improve solubility, increase chemical stability, or increase bioavailability of the active drug by decreasing first-pass metabolism
    • After oral administration, the inactive prodrug is converted to the active drug generally by biotransformation or hydrolysis

    Statistical Analysis for BE

    • No details provided

    Plasma Level and Urinary Excretion Parameters to Drug BA

    • No details provided

    Review Process for NDA and ANDA

    • No details provided

    BE for Specific Drugs and Drug Products

    • Oral solution
    • Chewable tablets
    • Orally administered drugs intended for local action
    • BE of topical drug products for local action
    • Inhalation and nasal sprays for local drug action
    • Alcohol effects on MR drug products
    • Endogenous substances
    • Long half-life drugs
    • Drug products with high intrasubject variability
    • Drug products with complex mixtures as the active ingredients

    Waivers of In Vivo BE Studies

    • BE studies in vitro dissolution testing may be used in lieu of in vivo BE studies for time-sensitive or environment-dependent products
    • Examples: Enteric coated

    Types of MR Oral Drug Products

    • Targeted-release drug products: release drug at or near the intended physiologic site of action
    • Orally disintegrating tablets: disintegrate rapidly in the saliva after oral administration
    • Extended release drug products: dosage form releases drug over an extended period of time after administration
    • Delayed release drug products: dosage form releases a discrete portion/portions of drugs at a time later than immediately after administration

    Advantages of Extended Release Products

    • Sustained therapeutic blood levels of the drug
    • Improved patient compliance
    • Reduction in adverse side effects and improvement in tolerability
    • Reduction in healthcare cost

    Disadvantages of Extended Release Products

    • Dose dumping: release of more than the intended fraction or greater rate
    • Less flexibility in accurate dose adjustments
    • Less possibility for high dosage
    • Increased potential for first-pass clearance
    • Poor IVIV correlation

    Generic Substitution

    • Positive Formulary: lists therapeutically equivalent or interchangeable drug products that pharmacists may dispense
    • Negative Formulary: lists drug products that are not therapeutically equivalent, and/or the interchange of which is prohibited

    Therapeutic Equivalence

    • Therapeutic Equivalence is assumed for a generic product if:
    • Approved as safe and effective
    • Are pharmaceutically equivalent
    • Are bioequivalent
    • Adequately labeled
    • Manufactured in compliance with Current Good Manufacturing Practice regulations

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    Description

    Test your knowledge of bioequivalence and bioavailability, including methods for assessing BA and BE, regulatory differences, and key concepts like biowaivers and prodrugs. This quiz covers the fundamentals of BA and BE in pharmaceutical development.

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