Pharm Study Guide I

Pharm Study Guide I - PharmacologyStudy Guide Terminology...

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PharmacologyStudy Guide Terminology Pharmacology – study of the effect of chemical substances on living systems Pharmacotherapeutics –effects of drugs in the human system for various disorders Pharmacodynamics –experimental science pertaining to theories of drug action Pharmacokinetics – study of drug’s alterations as it is absorbed, distributed, bound to or localized in tissues, biotransformed and excreted Pharmacogenetics – study of genetically-induced drug responses that are often responsible for some idiosyncratic responses Drugs FDA includes any substance listed in the USP or British pharmacopedia and all substances other than food or devices capable of altering body structure or function Basic function – a drug can only facilitate normal cellular function, effect change by: 1. Stimulation or depression of target cell activity 2. Replacement of deficient subsystems 3. Killing or weakening foreign invading organisms 4. Irritation General properties: 1. Modify existing functions 2. Exert multiple actions rather than a single effect 3. Drug function is a result of a physiochemical interaction between the drug and a functionally important molecule in the body Methods used to determine potency: 1. Chemical assay - chemical analysis to determine ingredients and amount 2. Bioassay - determines amount of solution need to produce a desired effect on a lab animal under certain conditions Steps in drug development Preclinical testing (in animals) o Animal studies – look for toxicity (acute toxicity is represented by the LD50 (dose that is lethal in 50% of lab animals tested)), therapeutic index (ratio of median lethal dose (LD50) to the median effective dose), Investigational New Drug (IND) status Clinical testing (in humans) Phase I – normal volunteers, tests for metabolism and biological effects Phase II – patients, tests for therapeutic utility and dosage range Phase III –patients, tests for safety and effectiveness Conditional approval of new drug application (NDA) Phase IV – early: limited, closely monitored marketing, late: unlimited marketing with postmarking surveillance Drug Schedules Schedule I –high potential for abuse, lack of accepted medical use (cocaine, heroin, LSD) Schedule II – high potential for abuse and high potential for psychological and/or physical dependence, but have accepted medical use (morphine, demoral)
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Schedule III – less potential for abuse, moderate potential for dependence (aspirin combined with codeine, barbituates) Schedule IV – low potential for abuse, limited potential for dependence (tranquilizers, chloral hydrate) Schedule V – very low potential for abuse and low potential for dependence (cough syrup with codeine) FDA pregnancy categories A – no risk to fetus B – no risk to animal fetus C – adverse effects recorded in animals
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Pharm Study Guide I - PharmacologyStudy Guide Terminology...

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