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Study of the action of the body on drugs. |
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Study of the action of drugs on the body. |
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Four principles of Pharmacokinetics |
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Absorption, Distribution, Metabolism, Elimination |
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The concentration of drug in the blood above which the risk of side effects or complications outweigh the benefits and below which therapeutic benefits are not seen. |
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The fraction or percentage of the drug that reaches the systemic circulation. |
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Blood from the GI tract passes through liver before systemic circulation; some drugs are significantly metabolized by the liver before reaching the systemic circulation. |
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Administration route that bypasses the GI tract. (IV, IM, SC) |
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A drug that will breakdown in an acidic environment like the stomach. |
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The apparent volume into which a drug distributes in the body at equilibrium. Amount in body(mg)/plasma drug concentration (mg/L) |
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Small volume of distribution |
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Definition
hydrophilic, trapped in plasma |
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lipophilic, distributes to the tissues |
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Drug metabolized by the Cytochrome P450 system (most lipophilic drugs) |
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Drug that causes more rapid metabolism of substrate drugs. |
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Drug that causes slower metabolism of substrate drugs. |
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Drug is oxidized or reduced to a more polar form usually in the liver. |
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Polar group in conjugated to the drug to increase polarity. |
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Inactive substance metabolized to an active substance in the body. |
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Metabolite that also has therapeutic activity. |
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Drugs diffuse from blood into nephron if they are small, unbound, nonionic. |
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Active transport of drugs into nephron, usually because they resemble something endogenous. |
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Drugs reenter the blood stream by diffusion from the nephron tubule if they are small and nonionic. |
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The time it takes the plasma concentration of a drug to decrease by 50% after a given dose. |
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When absorption equals elimination. The drug in the body is in homeostasis. Generally reached in 5 half-lives. |
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The component of a cell or organism that interacts with a drug and initiates the chain of biochemical events leading to a drug's observed effects. |
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Definition
Alters the physiology of a cell by binding to the plasma membrane or intracellular receptors. |
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Inhibits or blocks responses cause by agonists. |
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Absorption Drug Interactions |
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Definition
Increase or decrease the amount of drug absorbed. Avoid by taking at different times. (i.e. antacids decrease the amount of phenytoin absorbed) |
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Distribution Drug Interactions |
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Definition
Caused by plasma protein binding competition which increases the concentration of unbound drug. This is transient and it will return to baseline. (i.e. If you take aspirin while on phenytoin, aspirin has a higher protein binding affinity than phenytoin so it will bind and displace phenytoin therefore increasing the unbound concentration) |
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Metabolism Drug Interactions |
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Definition
Induction or inhibition of the Cytochrome P450 system. (i.e. if you take cimetidine while on phenytoin it is an inhibitor of P450 so it will increase the concentration of phenytoin because it isn't being metabolised as quickly; if you add carbamazepine it will decrease the concentration of phenytoin because it is an inducer of the P450 system and will speed metabolism) |
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Elimination Drug Interactions |
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Decreased or increased elimination of a drug. |
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1 + 1 = 2, two drugs are taken together and both exert their effects |
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1 + 1 = 3, two drugs are taken together and they enhance each others effects |
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0 + 1 = 2, one drug has no clinical activity alone, but when added to a clinically active drug it enhances its effects |
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1 + 1 = 0, one drug negates the other |
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Drugs that have the same effect on the body and a nearly identical chemical structure; same class |
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Drugs that have essentially the same effect on the body, but do not have an identical structure |
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An initial dose that is larger than subsequent doses for the purpose of achieving therapeutic drug concentrations more rapidly. Equal to the volume of distribution of the drug times the plasma concentration you desire |
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The dose of drug that attempts to maintain a steady state plasma concentration in the therapeutic range. |
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Pure Food and Drug Act of 1906 |
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Definition
Required labeling to help prevent adulteration; impetus was the sale of patent meds that were toxic |
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Food, Drug and Cosmetic Act of 1938 |
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Definition
Required drugs to be safe; established FDA; impetus was sulfanilamide elixir that killed 100 |
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Durham-Humphrey Amendment of 1952 |
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Distinction between nonprescription and prescription |
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Kefauver-Harris Amendments of 1962 |
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Definition
Efficacy and safety; impetus was thalidomide |
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Orphan Drug Amendments of 1983 |
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Definition
Tax benefits for treating rare diseases |
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Drug Price Competition and Patent Restoration Act of 1984 |
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Definition
Extended patent life; accelerated generics NDA |
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Accelerated Drug Approval of 1992 |
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Definition
Accelerated drug approval for life-threatening conditions; impetus was AIDS |
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Discovery/Characterizations of New Drug |
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Definition
Isolate/Synthesize; Determine chemical/pharmaceutical properties |
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Definition
Determine pharmacokinetic/pharmacodynamic properties; animal testing |
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Outline properties, propose clinical studies |
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Definition
Drug safety and pharmacokinetics in healthy volunteers |
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Clinical Studies Phase II |
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Definition
Efficacy, safety and dose in small group of patients |
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Clinical Studies Phase III |
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Statistical evidence of drug safety and efficacy; larger group |
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Outline properties, report findings of clinical studies; propose labeling and indications |
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Postmarketing Surveillance |
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Definition
Gather and analyze voluntary reports of adverse effects |
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