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