Question | Answer |
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 |