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10 Cards in this Set
- Front
- Back
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What are pharmacokinetics? |
Pharmacokinetics is a subject which deals with what the body does to a drug. More specifically it deals with the absorption, distribution, metabolism and excretion of drugs. |
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What are pharmacodynamics? |
Pharmacodynamics is a subject which deals with how the drug acts on the body. More specifically it deals with the biochemical and physiological effects of drugs. |
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Describe some ways scientists can find new drug candidates. |
- They can modify already existing drugs or natural substances - They can find a target molecule in the body and try to create a compound which acts on this target - They can create compounds which resemble endogenous molecules |
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What occurs under preclinical trials?
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During preclinical trials the drug candidate is tested in animal models to look for toxic or unwanted effects. Researches will also use the information collected from preclinical trials to estimate a safe dose to be used in clinical trials.
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What occurs during phase Ia clinical trials? |
During phase Ia clinical trials a drug is given in a single dose to healthy male volunteers, to test the acute tolerance of the drug. |
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Why are only male volunteers used in phase Ia clinical trials? |
Because exposing females to potentially dangerous drugs might negatively affect their eggs. Males produce sperm continuously and therefore don't have this problem. |
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What occurs during phase Ib clinical trials? |
During phase Ib clinical trials the drug is given in repeated doses to healthy male volunteers, to test long-term tolerance. |
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What occurs during phase II clinical trials? |
During phase II clinical trials there will be pharmacodynamic and pharmacokinetic studies on patients taking the drug over a period of time |
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What occurs during phase III clinical trials? |
During phase III clinical trials the drug is tested for therapeutic effects in a large scale placebo-controlled double-blind study. |
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What occurs during phase IV clinical trials? |
During phase IV clinical trials the drug is already in the market. During this time there will be studies measuring the long-term effects and safety of the drug. |
