Term
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Definition
General: A chemical with biological effects
Legal: A chemical that is currently being used by the medical profession to diagnose, prevent, or treat disease |
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Term
| What are pharmacodynamics? |
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Definition
The actions of drugs on biochemical and physiological systems in the body
Characterizes the relationship of drug concentration at the site of action to the intensity of the biological effect |
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Term
| What are pharmacokinetics? |
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Definition
The fate of the drug in the body
Drug disposition - absorption, distribution, metabolism, and excretion (ADME)
Drug concentrations - defining the relationship of dose, route of administration and timing to achieve therapeutic concentrations of drugs
Drug effect - defining the relationship of dose, route of administration, and timing effect |
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Term
| In reference to drugs, what is indication? |
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Definition
| When a drug has been shown to have efficacy in a particular condition, it is said to have an "indication" for that disease state |
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Term
| In reference to drugs, what is contraindication? |
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Definition
| A drug is "contraindicated" when there are specific conditions in which the use of a particular drug in a specific patient could result in great harm |
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Term
| What are the 3 adverse effects of drugs? |
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Definition
Side effect - predictable due to mechanism of action of drug
Idiosyncratic - may be genetically linked but we have not identified the link yet; not apparently related to the action of the drug
Allergic/Hypersensitivity - immune mediated |
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Term
| How many patients recieving placebos in drug studies report effects? |
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Definition
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Term
| When is the placebo effect a problem? When is it less of a problem? |
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Definition
It is a problem when the effectiveness of a drug has a subjective endpoint (depression, pain)
It is less of a problem when there are objective measures of effects such as blood pressure or hemoglobin A1C |
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Term
| Drug response is determined by many factors, including? |
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Definition
| Age, gender, race, genetics, disease states, and other drugs |
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Term
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Definition
| The rate and extent to which an active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action |
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Term
| When oral formulations are made, how is the bioavailability determined? |
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Definition
| By comparing the serum levels produced by the oral formulation to those produced by the intravenous form; IV is considered to be 100% bioavailable |
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Term
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Definition
| When a generic formulation of a drug is made, the generic manufacturer must demonstrate that their new formulation has the same bioavailability as the proprietary formulation; +/- 20% it is a comparison of mean values |
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Term
| What does biosimilar mean? |
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Definition
Also called "follow-on biologics"
These are the second generation of recombinant DNA drugs such as insulin, human growth hormone, etc.
Unlike "chemical generics" it is impossible to exactly replicate a biologic |
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Term
| What is the therapeutic index of a drug? |
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Definition
A measure of the relative safety of a drug
A high therapeutic index indicates a high margin of safety
Ratio of LD50 to ED50 |
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