40 Questions
What is the term for the original product that is marketed by a company?
Innovator product
What is the process of a solid drug substance dissolving in a solvent?
Dissolution
What is the term for products that have the same strength, dosage form, and route of administration, but may have different inactive ingredients?
Pharmaceutical equivalents
What is the term for products that have different strengths, dosage forms, or routes of administration, but contain the same active ingredient?
Pharmaceutical alternatives
What is the most bioavailable oral drug formulation?
Solution
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?
77.38%
Which of the following products are considered to be pharmaceutical equivalents?
Amlodipine besylate 10 mg tab (innovator) & amlodipine besylate 10 mg tab (generic)
Which of the following products are considered to be pharmaceutical alternatives?
Nifedipine 5 mg cap & nifedipine 20 mg cap
When does the peak concentration following an IV infusion of a drug usually occur?
Immediately after the dose is given
What is the term for the process by which the pharmacokinetic parameters change during absorption, metabolism, and excretion due to increased dose size?
Saturation kinetics
What is the most frequently used assay method for therapeutic drug monitoring?
Radioimmunoassay
What graphical method is used to separate exponents such as the absorption rate constant from the elimination rate constant?
Residual Method
What occurs when the infusion of a drug stops?
Reduction
What is the term for the process by which the pharmacokinetic parameters change during absorption, metabolism, and excretion due to enzyme inhibition?
Enzyme Inhibition
What occurs after the distribution phase?
Auto oxidation
What is the term for the process by which the pharmacokinetic parameters change during absorption, metabolism, and excretion due to the first pass effect?
First pass effect
What is the primary mechanism of diffusion of a drug through membrane pores according to Fick's Law?
Passive diffusion
Which of the following absorption mechanisms operates against a concentration gradient?
Active transport
What is the correct rank order of bioavailability for the given conventional oral formulations?
Solution > suspension > capsule > uncoated tablet > coated tablet
What is the primary purpose of adding excipients to product formulations?
To improve the functioning of the dosage form as a drug delivery system
Which of the following statements is true about rate constants in pharmacokinetics?
They are usually expressed in units of time
Which of the following mechanisms of diffusion does not require energy?
Passive diffusion
What is the primary difference between facilitated diffusion and active transport?
The requirement for energy
Which of the following types of transport is driven by a concentration gradient?
Passive diffusion
What is the maximum drug concentration obtained after oral administration of a drug?
Cmax
Which of the following is a biophase?
compartment
What is the maximum volume that can be injected via the intramuscular route?
2 mL
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?
first-order reaction
What is the dose used to initiate therapy and achieve a therapeutic concentration?
loading dose
Which solvent is commonly used in partition coefficient determination?
octanol
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?
facilitated diffusion
What is the minimum effective concentration of a drug?
MEC
What occurs when absorbed drug passes directly through the liver before reaching the systemic circulation after oral administration?
First-pass metabolism
What is the usual research design for conducting bioavailability and bioequivalence studies?
Two-formulation, two-period, two-sequence non-replicate crossover design
What is the term for the binding of a drug to protein?
Reversible process
What occurs when a drug is absorbed directly into the liver?
First-pass metabolism
What is the term for the process of a drug being broken down in the stomach?
Hydrolysis of the drug in the stomach
What is the term for the process of a drug being transported by protein?
Transported by p-glycoprotein
What is the term for the study of the movement of drugs through the body?
Pharmacokinetics
What is the term for the process of a drug being filtered out of the blood by the kidneys?
Dialysis
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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