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Pharmacokinetic Principles
Terminology
53
Pharmacology
Graduate
09/21/2010

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Term
Pharmacokinetics
Definition
Study of the action of the body on drugs.
Term
Pharmacodynamics
Definition
Study of the action of drugs on the body.
Term
Four principles of Pharmacokinetics
Definition
Absorption, Distribution, Metabolism, Elimination
Term
Therapeutic Range
Definition
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.
Term
Bioavailability (F)
Definition
The fraction or percentage of the drug that reaches the systemic circulation.
Term
First Pass Effect
Definition
Blood from the GI tract passes through liver before systemic circulation; some drugs are significantly metabolized by the liver before reaching the systemic circulation.
Term
Parenteral
Definition
Administration route that bypasses the GI tract. (IV, IM, SC)
Term
Acid Labile
Definition
A drug that will breakdown in an acidic environment like the stomach.
Term
Volume of Distribution
Definition
The apparent volume into which a drug distributes in the body at equilibrium. Amount in body(mg)/plasma drug concentration (mg/L)
Term
Small volume of distribution
Definition
hydrophilic, trapped in plasma
Term
Large Vd
Definition
lipophilic, distributes to the tissues
Term
Substrate
Definition
Drug metabolized by the Cytochrome P450 system (most lipophilic drugs)
Term
Inducer
Definition
Drug that causes more rapid metabolism of substrate drugs.
Term
Inhibitor
Definition
Drug that causes slower metabolism of substrate drugs.
Term
Phase I Reactions
Definition
Drug is oxidized or reduced to a more polar form usually in the liver.
Term
Phase II reactions
Definition
Polar group in conjugated to the drug to increase polarity.
Term
Prodrug
Definition
Inactive substance metabolized to an active substance in the body.
Term
Active metabolite
Definition
Metabolite that also has therapeutic activity.
Term
Filtration
Definition
Drugs diffuse from blood into nephron if they are small, unbound, nonionic.
Term
Secretion
Definition
Active transport of drugs into nephron, usually because they resemble something endogenous.
Term
Reabsorption
Definition
Drugs reenter the blood stream by diffusion from the nephron tubule if they are small and nonionic.
Term
Half-Life
Definition
The time it takes the plasma concentration of a drug to decrease by 50% after a given dose.
Term
Steady State
Definition
When absorption equals elimination. The drug in the body is in homeostasis. Generally reached in 5 half-lives.
Term
Receptor
Definition
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.
Term
Agonist
Definition
Alters the physiology of a cell by binding to the plasma membrane or intracellular receptors.
Term
Antagonist
Definition
Inhibits or blocks responses cause by agonists.
Term
Absorption Drug Interactions
Definition
Increase or decrease the amount of drug absorbed. Avoid by taking at different times. (i.e. antacids decrease the amount of phenytoin absorbed)
Term
Distribution Drug Interactions
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)
Term
Metabolism Drug Interactions
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)
Term
Elimination Drug Interactions
Definition
Decreased or increased elimination of a drug.
Term
Addition
Definition
1 + 1 = 2, two drugs are taken together and both exert their effects
Term
Synergism
Definition
1 + 1 = 3, two drugs are taken together and they enhance each others effects
Term
Potentiation
Definition
0 + 1 = 2, one drug has no clinical activity alone, but when added to a clinically active drug it enhances its effects
Term
Antagonism
Definition
1 + 1 = 0, one drug negates the other
Term
Bioequivalence
Definition
Drugs that have the same effect on the body and a nearly identical chemical structure; same class
Term
Therapeutic Equivalence
Definition
Drugs that have essentially the same effect on the body, but do not have an identical structure
Term
Loading dose
Definition
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
Term
Maintenance Dose
Definition
The dose of drug that attempts to maintain a steady state plasma concentration in the therapeutic range.
Term
Pure Food and Drug Act of 1906
Definition
Required labeling to help prevent adulteration; impetus was the sale of patent meds that were toxic
Term
Food, Drug and Cosmetic Act of 1938
Definition
Required drugs to be safe; established FDA; impetus was sulfanilamide elixir that killed 100
Term
Durham-Humphrey Amendment of 1952
Definition
Distinction between nonprescription and prescription
Term
Kefauver-Harris Amendments of 1962
Definition
Efficacy and safety; impetus was thalidomide
Term
Orphan Drug Amendments of 1983
Definition
Tax benefits for treating rare diseases
Term
Drug Price Competition and Patent Restoration Act of 1984
Definition
Extended patent life; accelerated generics NDA
Term
Accelerated Drug Approval of 1992
Definition
Accelerated drug approval for life-threatening conditions; impetus was AIDS
Term
Discovery/Characterizations of New Drug
Definition
Isolate/Synthesize; Determine chemical/pharmaceutical properties
Term
Experimental Studies
Definition
Determine pharmacokinetic/pharmacodynamic properties; animal testing
Term
IND Application
Definition
Outline properties, propose clinical studies
Term
Clinical Studies Phase I
Definition
Drug safety and pharmacokinetics in healthy volunteers
Term
Clinical Studies Phase II
Definition
Efficacy, safety and dose in small group of patients
Term
Clinical Studies Phase III
Definition
Statistical evidence of drug safety and efficacy; larger group
Term
Submission of NDA
Definition
Outline properties, report findings of clinical studies; propose labeling and indications
Term
Postmarketing Surveillance
Definition
Gather and analyze voluntary reports of adverse effects
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