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Biopharmaceutics Exam 1 Terms and Definitions
Biopharmaceutics Exam 1 Terms and Definitions
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09/15/2010

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Term
Drug Delivery
Definition
The series of processes that result in drug molecules reaching their intended site of action following administration of a drug product.
Term
Drug
Definition
A chemical compound that interacts with specific cells in the body to produced desired effects in a patient.
Term
Pharmacology
Definition
The study of the biological mechanisms by which drugs exert their effects.
Term
Phamacogenomics
Definition
The study of the effects of gene expression patterns on drug responses, promises to transform healthcare by allowing customized drug therapies for individual patients.
Term
Dose
Definition
The amount of a dug administered to a patient.
Term
Medicinal Chemistry
Definition
The study of the effects of chemical structure on drug properties.
Term
Drug Product
Definition
A mixture of one or more drugs with excipients (inactive ingredients) in an appropriate dosage form.
Term
Dosage Form
Definition
Refers to the physical form of a drug product, e.g. tablet, IV injection, topical cream.
Term
Active Pharmaceutical Ingredients
Definition
The drugs within the tablet, capsule, etc.
Term
Route of Administration
Definition
The path by which a drug product is introduced to the body.
Term
Oral Administration
Definition
Where a patient swallows a drug product and the drug is absorbed into the blood forom the GI Tract or exerts its effects directly in the GI tract.  It is the preferred route for patients and physicians.
Term
Local
Definition
At the administration site
Term
Systemic
Definition
Throughout the body
Term
Pharmacokinetics
Definition
The quantitative study of the rates of drug transport into absorption, within (distribution), and out of (elimination) the body.
Term
Dosage Regimen
Definition
Dose and frquency of administration.
Term
Absorption
Definition
Refers to processes that result in the drug being transported from the site of administration into the blood.
Term
Elimination
Definition
Refers to processes that result in active drug molecules being removed from the body by various excretion and metabolism processes.
Term
Duration of action
Definition
The period of time over which a dose of drug can be expected to exert its desired effect.
Term
Pharmaceutics
Definition
The study of physical chemical properties of drug substances and drug products, and their impacts on in vivo drug product performance and effectiveness.
Term
Formulation
Definition
The design and large scale manufacture of drug products.
Term
Biopharmaceutics
Definition
The study of formulation, administration, and physiological variables on drug product performance in vivo.
Term
Transport
Definition
Movement of drug molecules from one compartment through a barrier into another compartment e.g. from blood to the brain.
Term
Physical transformation
Definition
Changes in the physical state of a drug substance or drug product.
Term
Prodrugs
Definition
Inactive molecules that generate an active drug molecule once absorbed into the body, require chemical activation as part of the drug delivery process.
Term
Distribution
Definition
Drug molecule transport from the blood into other body tissues.
Term
"Blood Brain Barrier" (BBB)
Definition
The Central Nervous Stem Capillary System, limits distribution of drugs and toxins into the brain.
Term
Partition Coefficient (K)
Definition
Expression of lipophilicity, the ratio of drug solubility in octanol to its solubility in water.
Term
Side effects or adverse reactions
Definition
The unintended pharmacologic effect
Term
Metabolize
Definition
Chemically degrade susceptible drug molecules
Term
Metabolites
Definition
The chemical products of metabolism
Term
Minimum Effective Concentration (MEC)
Definition
The lowest Cp value that elicits the intended pharmacologic response.
Term
Genetic Polymorphisms
Definition
Variation in the normal genetic sequences of some hepatic enzymes.
Term
Induce
Definition
Cause an increase in expression
Term
Inhibit
Definition
Cause a decrease in activity.
Term
Pathophysiology
Definition
The effects of disease on body functions, may alter drug elimination processes.
Term
Excretion
Definition
The transport of unchanged drug molecules from the blood into the urine, bile, milk, or saliva, is another form of elimination.
Term
Plasma Protein Binding
Definition
It is the best understood interaction between blood components and drug molecules.
Term
Absorption
Definition
The series of process involved in the transport of drug molecules from an absorption site into circulation.
Term
First Pass Metabolism
Definition
Drug metabolism during the absorption process
Term
Absolute Bioavailability
Definition
The fraction of an administered dose of drug that is absorbed into the systemic circulation.
Term
Gastric Emptying
Definition
The stomach propels its contents into the small intestine by peristalsis.
Term
Dissolve
Definition
The drug particles must be exposed to and disperse in the solvent.
Term
Disintegrate
Definition
Break apart into smaller particles.
Term
Dissolution
Definition
The process by which solid particles dissolve.
Term
Administration
Definition
The process where a drug product is introduced to the body.  The first step in drug delivery process.
Term
Shelf Life
Definition
The duration of time over which the product will perform as expected if it is stored according to the label directions.
Term
Expiration Date
Definition
The date beyond which the product should be discarded because its quality cannot guaranteed.
Term
Recall
Definition
An announcement to stop using or dispensing affected batches of a product and return them to the manufacturer.
Term
Onset of Action
Definition
The amount of time required for the drug to exert a measureable pharmacologic effect (pain relief) after administration, than oral administration.
Term
Pharmaceutical Compounding
Definition
The preparation of a customized drug product for an individual patient by a pharamacist.
Term
Kinetic Homogeneity
Definition
When Cp increases, drug concentration in the tissue decreases proportionally.  This relationship is referred to as kinetic homogeniety.
Term
Intravenous (IV) bolus injection AKA IV Push or IV Injection
Definition
Rapid introduction of a drug solution directly into the systemic venous blood circulation.
Term
Intravenous Infusion
Definition
The slow introduction of drug solution into venous blood circulation, typically over a period 15 minutes to several hours.
Term
Input Rate
Definition
The positive contribution to delta Cp per unit time e.g. mg/L/min.
Term
Output Rate
Definition
Negative contribution to delta Cp per unit time.
Term
Order
Definition
Drug Concentration dependence of process.
Term
Half Life
Definition
The time required for drug concentration to decrease to 1/2 of it's starting concentration when there is no drug input occuring. This can be determined by Cp vs. Time Graph.
Term
Superposition
Definition
The concept in which Cp instaneously increases by the quantity (Dose/VD).
Term
Steady State Plasma Concentration (Cpss)
Definition
The point at which the elimination rate increse to exactly match the infusion rate. Cp no longer increases.
Term
Absolute Bioavailability
Definition
The fraction of the administered dose (D0) that is ultimately absorbed into the systemic circulation.
Term
Minimum Toxic Concentration (MTC)
Definition
The lowest Cp value that results in undesirable toxic response.
Term
Therapeutic Window/Index/Range
Definition
The range of Cp values between MEC and MTC.
Term
Population Averages
Definition
Meaning they were calculated as an average from testing the drug in many individual subjects.
Term
Pharmacokinetic Variability
Definition
The phenomenon where a drug exhibits different pharmacokinetics in individual people.
Term
Pharmacodynamic Variability
Definition
A phenomenon where individual people experience different intensities of pharmacologic response to a drug with the same Cp versus time profile.
Term
Secretion
Definition
Refers to an active, rather than passive, excretion process.
Term
Washout period
Definition
The duration of time allowed for the first dose of drug to be completely eliminated before the second dose is administered.
Term
Crossover Design
Definition
The experimental design where the smae group of volunteers takes both the IV and oral doses of the drug.
Term
Parallel Design
Definition
The experimental design where one group of volunteers receives an IV dose and a different group of volunteers receives an oral dose.
Term
Assay
Definition
Method used to measure the drug level.
Term
Relative Bioavailability
Definition
The fraction of an administered dose that is absorbed into systemic circulation blood as compared to a comparison (or reference) product.
Term
Topical Administration
Definition
Involves applying product to skin for local effects
Term
Transdermal Administration
Definition
Refers to application of product to skin for systemic effect.
Term
Intranasal Administration
Definition
Application of a drug in the nose for local or systemic effects.
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