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Chap - 2

Pharmacology HIM1442

drugs from ancient sources were originally derived from plant, animal, or mineral sources
drugs from a totally new chemical can be discovered in environment from plants, animals, oceans, or soil
originally derived from needles of Pacific yew tree; used for chemo Taxol
drugs from a totally new chemical can be derived from molecular manipulation of drug that is already in use
drug that has same chemical formula as another drug, but has those atoms arranged in different way isomer
totally new drugs can be created through genetic manipulation
involves using enzymes in a test tube to cut apart segment of DNA molecule; clone it; attach back together with bacterial cell recombinant DNA (rDNA) technology
group of physicians & pharmacists who review clinical trials of genetically engineered new drugs & make recommendations to FDA Recombinant DNA Advisory Committee
involves use if stem cells to repair/replace damaged cells in body stem cell therapy
normal version of gene is linked to harmless virus; virus carries gene into body cells affected by disease gene therapy
computer database where researchers are able to do an online match between genetic profile of a disease & genetic profile of drug that could be used to treat that disease The Connectivity Map
accurately described its molecular structure & distinguishes it from all other chemicals chemical name
2nd name for a drug determined by drug company together with US Adopted Names (USAN) Council generic name
after FDA give final approval for marketing, drug company creates 3rd name brand/trade name
drug manufacturer selects trade name that indicates type of disease condition/symptom drug being used to treat
drug manufacturer selects trade name that indicates what __ __ __ is being treated part of body
drug manufacturer selects trade name that indicates __ or __ of drug ingredients; source
drug manufacturer selects trade name that indicates __ __ of drug therapeutic effect
drug manufacturer selects trade name that indicated how __ drug is to be taken often
number of animals that respond/do no respond to drug & at what dose frequency distribution curve
time required for drug level in serum to decrease from 100% to 50%; can be prolonged significantly when liver/kidney diseases decrease metabolism/excretion of drug half-life
the short a drug's half-life the more frequently it must be given
dose at which 50% of animals tested show therapeutic response to drug median effective dose (ED50)
dose at which 50% of animals tested had toxic levels of drug median toxicity dose (TD50)
relative margin of safety between dose that produces therapeutic effect & dose that produces lethal effect in animals therapeutic index (TI)
three phases of human testing for a new drug clinical trials
about 10-100 healthy volunteers are used to study a safe dose range, evaluate side effects, & establish final correct dose; informed consent mandatory; takes about 1-1/2 yrs Phase I clinical trials
drug is given on experimental basis to about 50-500 patients who actually have disease; determines extent of therapeutic effect; takes about 2yrs Phase II clinical trials
drug administered to several hundred-thousands of ill patients in exactly way in which it will be used once it is on market; performance comparison done w/similar drugs on market; usually lasts about 3 years Phase III clinical trials
drug & placebo are administered, without patient/doctor knowing who receives drug/placebo double-blind study
chemical analysis of drug in lab in test tubes; means in glass in vitro testing
testing carried out in animals/humans in vivo testing
precedes testing on humans animal testing
using mathematics to described the mechanism of action by which drug produces its effects based on time/dose pharmacodynamics
after completion of animal studies company submits IND (Investigational New Drug) Application
IND (Investigational New Drug) Application contains info about animal trials; shows drug not a risk to humans; includes chemistry of drug & manufacturing process
first benzodiazepine drug was chlordiazepoxide (Librium). In identifying this drug chlordiazepoxide is the _________ name generic
ending of the generic name for a drug is -olol, therefore the drug is classified as a beta blocker for hypertension and arrhythmias
by recognizing the ending of a generic name for tranquilizers, select the medication used for anxiety and neurosis oxzepam
clinical trials for a new drug generally take about 6-1/2 years
Created by: lfrancois