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Definition
| Extent to which a drug is able to reach cellular receptors and makes its effect felt in the body. That portion of the total drug dose that, after absorption, is actually available to interact with receptors and produce a therapeutic effect. Bioavailability is determined by a number of factors influencing absorption, including drug composition (inert fillers and buffers), drug particle size, and stomach pH. Bioavailability can be tested by obtaining a blood level of the drug after it has been administered. |
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Definition
| Mandatory, three-phase animal and human testing of a drug by the drug company before it can be approved for marketing by the FDA. |
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Definition
| Group of patients during a clinical trial who receive a placebo rather than the actual drug being tested. Neither the patients nor the physician-investigators know which patients are receiving the drug and which patients are in the control group and receive the placebo during clinical drug trials. |
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Definition
| A packet of moisture-absorbing silica gel that is added to a drug container to keep the individual tablets or capsules from deteriorating or losing strength if exposed to moisture. |
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Definition
| Action by the FDA to remove from the market all (or certain batches of) a prescription or over-the-counter drug. This can be done because there is an incorrect amount of active ingredients in the drug, the drug does not remain stable until the expiration date, or the drug is contaminated with particulate matter. A drug recall can also be done by the drug company itself. |
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Definition
| Name given to a chemical substance by the drug company together with the United States Adopted Names (USAN) Council. There is always ones generic drug name related to a specific chemical name. |
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Definition
| The time required for a drug level in the blood decrease from 100% to 50%. The half-life is prolonged if liver or kidney disease results in decreased metabolism or excretion of a drug. The shorter the drug's half-life, the more frequently it must be administered to maintain a therapeutic level in the blood. |
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Definition
| Testing of a drug that is done in a laboratory in test tubes (in vitro is Latin for in glass). |
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Definition
| Testing of a drug that is carried out in animals or humans (in vivo is Latin for living). |
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Definition
| A drug that has the same chemical formula (the same types and numbers of atoms in its molecule) as another drug, but has those atoms arranged in a different way--either with different chemical bonds or in a different structural relationship to each other. |
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Definition
| The study of how the genetic makeup of different people affects their response to certain drugs. |
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Definition
| A substance that exerts no pharmacologic effect, no therapeutic effect, and no side effects when administered. Placebos are used in double-blind research studies in which neither the researcher nor the patient knows whether the medication given was the drug being tested or was a placebo. Placebos are commonly sugar pills or injections or sterile normal saline. |
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Term
| recombinant DNA technology (also gene splicing and genetic engineering) |
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Definition
| Drug design and production technology that uses enzymes in a test tube (in vitro) to cut apart a segment of a DNA molecule from a human cell. This segment specifically directs the production of a particular substance in the body. The technique of gene cloning allows the production of a large supply of this DNA segment. The DNA segments are then spliced (recombined) with the DNA in a bacterial cell. The bacteria are now preprogrammed to make supplies of that particular substance. |
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Term
| trade name (also brand name or proprietary name) |
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Definition
| Drug name selected by the drug company when the FDA gives final approval for marketing. The trade name is specifically designed to be easy to remember and, if possible, to suggest how the drug is used. Proprietary is a legal word that expresses ownership. |
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Definition
| The study of using human genome technology to create new drugs. |
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Definition
| The mechanism of action by which drugs produce their effects (desired or undesired) based on time and dose. It includes determining the frequency distribution curve, median effective dose, median toxicity dose (in animals), half-life, and therapeutic index. |
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Term
| frequency distribution curve |
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Definition
| Mathematical representation that shows the number of people who respond or do not respond to a particular drug at particular doses. This is calculated during the clinical trials of a drug. |
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Term
| medican effective dose (ED50) |
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Definition
| The dose at which 50% of animals tested show a therapeutic response to the drug. |
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Term
| median toxicity dose (TD50) |
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Definition
| The dose at which 50% of animals tested had a toxic level of the drug. |
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Definition
| The relative margin of safety between the dose that produces a therapeutic effect and the dose that produces a lethal effect in animals. The high the therapeutic index, the more desirable, because it indicates that the drug has a wide margin of safety. |
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Definition
| Substances such as binders and fillers that are used to change the shape of a drug tablet but are inactive in the body. |
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Definition
| A small packet (unit-dose) that has a piece of cardboard printed with the drug's name and dose on it and a bubble of clear plastic that encloses each single dose of a capsule to tablet. |
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