PCOL & TOXI
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Questions and Answers

What is the term for the original product that is marketed by a company?

  • Reference product
  • Innovator product (correct)
  • Pharmaceutical equivalent
  • Market leader

    • What is the process of a solid drug substance dissolving in a solvent?

  • Distribution
  • Absorption
  • Dissolution (correct)
  • Liberation

    • What is the term for products that have the same strength, dosage form, and route of administration, but may have different inactive ingredients?

  • Pharmaceutical alternatives
  • Multi-source drug products
  • Innovator products
  • Pharmaceutical equivalents (correct)

    • What is the term for products that have different strengths, dosage forms, or routes of administration, but contain the same active ingredient?

    <p>Pharmaceutical alternatives</p> Signup and view all the answers

    What is the most bioavailable oral drug formulation?

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

    What is the relative bioavailability of the Phenobarbital tablet if the AUC is 6.5 mcg/mL x hr and the AUC for the Phenobarbital solution is 8.4 mcg/mL x hr?

    <p>77.38%</p> Signup and view all the answers

    Which of the following products are considered to be pharmaceutical equivalents?

    <p>Amlodipine besylate 10 mg tab (innovator) &amp; amlodipine besylate 10 mg tab (generic)</p> Signup and view all the answers

    Which of the following products are considered to be pharmaceutical alternatives?

    <p>Nifedipine 5 mg cap &amp; nifedipine 20 mg cap</p> Signup and view all the answers

    When does the peak concentration following an IV infusion of a drug usually occur?

    <p>Immediately after the dose is given</p> Signup and view all the answers

    What is the term for the process by which the pharmacokinetic parameters change during absorption, metabolism, and excretion due to increased dose size?

    <p>Saturation kinetics</p> Signup and view all the answers

    What is the most frequently used assay method for therapeutic drug monitoring?

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

    What graphical method is used to separate exponents such as the absorption rate constant from the elimination rate constant?

    <p>Residual Method</p> Signup and view all the answers

    What occurs when the infusion of a drug stops?

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

    What is the term for the process by which the pharmacokinetic parameters change during absorption, metabolism, and excretion due to enzyme inhibition?

    <p>Enzyme Inhibition</p> Signup and view all the answers

    What occurs after the distribution phase?

    <p>Auto oxidation</p> Signup and view all the answers

    What is the term for the process by which the pharmacokinetic parameters change during absorption, metabolism, and excretion due to the first pass effect?

    <p>First pass effect</p> Signup and view all the answers

    What is the primary mechanism of diffusion of a drug through membrane pores according to Fick's Law?

    <p>Passive diffusion</p> Signup and view all the answers

    Which of the following absorption mechanisms operates against a concentration gradient?

    <p>Active transport</p> Signup and view all the answers

    What is the correct rank order of bioavailability for the given conventional oral formulations?

    <p>Solution &gt; suspension &gt; capsule &gt; uncoated tablet &gt; coated tablet</p> Signup and view all the answers

    What is the primary purpose of adding excipients to product formulations?

    <p>To improve the functioning of the dosage form as a drug delivery system</p> Signup and view all the answers

    Which of the following statements is true about rate constants in pharmacokinetics?

    <p>They are usually expressed in units of time</p> Signup and view all the answers

    Which of the following mechanisms of diffusion does not require energy?

    <p>Passive diffusion</p> Signup and view all the answers

    What is the primary difference between facilitated diffusion and active transport?

    <p>The requirement for energy</p> Signup and view all the answers

    Which of the following types of transport is driven by a concentration gradient?

    <p>Passive diffusion</p> Signup and view all the answers

    What is the maximum drug concentration obtained after oral administration of a drug?

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

    Which of the following is a biophase?

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

    What is the maximum volume that can be injected via the intramuscular route?

    <p>2 mL</p> Signup and view all the answers

    What type of reaction is characterized by a decrease in concentration of a drug at a rate proportional to the concentration of the drug remaining?

    <p>first-order reaction</p> Signup and view all the answers

    What is the dose used to initiate therapy and achieve a therapeutic concentration?

    <p>loading dose</p> Signup and view all the answers

    Which solvent is commonly used in partition coefficient determination?

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

    What is the process by which a substance moves from an area of higher concentration to an area of lower concentration, facilitated by a transport protein?

    <p>facilitated diffusion</p> Signup and view all the answers

    What is the minimum effective concentration of a drug?

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

    What occurs when absorbed drug passes directly through the liver before reaching the systemic circulation after oral administration?

    <p>First-pass metabolism</p> Signup and view all the answers

    What is the usual research design for conducting bioavailability and bioequivalence studies?

    <p>Two-formulation, two-period, two-sequence non-replicate crossover design</p> Signup and view all the answers

    What is the term for the binding of a drug to protein?

    <p>Reversible process</p> Signup and view all the answers

    What occurs when a drug is absorbed directly into the liver?

    <p>First-pass metabolism</p> Signup and view all the answers

    What is the term for the process of a drug being broken down in the stomach?

    <p>Hydrolysis of the drug in the stomach</p> Signup and view all the answers

    What is the term for the process of a drug being transported by protein?

    <p>Transported by p-glycoprotein</p> Signup and view all the answers

    What is the term for the study of the movement of drugs through the body?

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

    What is the term for the process of a drug being filtered out of the blood by the kidneys?

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

    Study Notes

    Innovator Products

    • A drug product that is marketed under a brand name by a manufacturer that has developed the product.

    Pharmaceutical Equivalents

    • Products with the same active ingredient, dosage form, strength, and route of administration.

    Bioavailability

    • Relates to the rate and extent of absorption of a drug from a pharmaceutical formulation.

    Dissolution

    • The process by which a solid drug substance becomes dissolved in a solvent.

    Pharmaceutical Alternatives

    • Drug products that contain the same active ingredient, but may differ in other characteristics such as dosage form, strength, or route of administration.

    Bioavailable Formulations

    • A solution is considered to be the most bioavailable oral drug formulation.

    Maximum Volume for Intramuscular Injection

    • The maximum volume to be injected via the intramuscular route is 2 mL.

    Loading Dose

    • The dose used in initiating therapy to yield therapeutic concentration, which will result in clinical effectiveness.

    Fick's Law

    • The rate of diffusion of a drug is directly proportional to the concentration gradient and the surface area, and inversely proportional to the thickness of the membrane.

    Facilitated Diffusion

    • A type of passive transport that uses transport proteins to facilitate the movement of molecules across the cell membrane.

    Active Transport

    • A type of transport that requires energy, often in the form of ATP, to move molecules across the cell membrane against their concentration gradient.

    Pharmacokinetics

    • The study of the movement of drugs within the body, including absorption, distribution, metabolism, and excretion.

    Rate Constants

    • Usually expressed in terms of the rate of absorption, distribution, metabolism, or excretion of a drug.

    Peak Concentration Following IV Infusion

    • The peak concentration following an IV infusion of a drug usually occurs immediately after the dose is given.

    Graphical Method for Separation of Exponents

    • A method used to separate the absorption rate constant from the elimination rate constant.

    Therapeutic Drug Monitoring

    • The process of measuring drug concentrations in the blood to adjust the dosage of a medication.

    Assay Methods

    • Radioimmunoassay, Gas Chromatography, Microbiological assay, and Enzyme multiplied immunoassay are common methods used for therapeutic drug monitoring.

    Non-Linear Kinetics

    • A change in one or more of the pharmacokinetic parameters during absorption, metabolism, and excretion due to saturation or overloading of processes.

    First-Pass Metabolism

    • The process by which a drug is metabolized by the liver before it reaches the systemic circulation after oral administration.

    Bioavailability and Bioequivalence Studies

    • A two-formulation, two-period, two-sequence non-replicate crossover design is the usual research design used for conducting bioavailability and bioequivalence studies.

    Drug Binding to Protein

    • A reversible process that can be considered linear or non-linear.

    Importance of Drug-Protein Binding

    • It can affect the distribution and elimination of a drug from the body.

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