pharmacodynamics Correct Answer-what the drug does to the body
pharmacologists Correct Answer-Individuals who study pharmacology
and the interactions of drugs on living
systems
Pharmacists, Physicians,
Others Correct Answer-Individuals who practice pharmacotherapy
Preclinical Studies Correct Answer-animal testing of new compound
towards a variety of diseases and conditions
Phase I Correct Answer-Generally in young, healthy, male volunteers
Safety in limited population
,Phase II Correct Answer-Finally tested in affected population Testing
efficacy in limited target/sick population (hundreds)
Phase III Correct Answer-Safety and efficacy in large, target/sick
population (thousands) New drug application (NDA) submitted to FDA
PHASE IV Correct Answer-Drug has been approved and is in use in the
general population Additional data is collected and adverse events are
reported Drugs may be recalled if harm is shown to a sufficient degree
ex.
Cisapride (Propulsid®) Troglitazone (Rezulin®)
Rofecoxib (Vioxx®)
schedule 1 Correct Answer-Highest abuse potential; no accepted,
medicinal use
ex. heroin: LSD, Marijuana
schedule II Correct Answer-High abuse potential
ex. morphine; hydrocodone;
amphetamines
schedule III Correct Answer-Moderate abuse potential
ex. testosterone; butabarbital
schedule IV Correct Answer-Lower abuse potential
, ex. benzodiazepines; hypnotics
schedule V Correct Answer-Lowest abuse potential
ex. cough syrups with small amt of codeine
Orphan Drugs Correct Answer-FDA assistance for drug research with
low population thats affected, diseases affecting less then 200,000
people in US
Off-Label Prescribing Correct Answer-when a drug is prescribe for
condition they were not approved to treat
Median effective dose (ED50)- Correct Answer-Dose at which 50% of
the population response to the drug in a specified
manner
Median toxic dose (TD50)- Correct Answer-Dose at which 50% of the
population
exhibits adverse effect
Median lethal dose (LD50)- Correct Answer-Dose at which 50% of
animal population died
therapeutic index Correct Answer-Ratio between median effective dose
and median toxic/lethal dose: Indicator of drug safety
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