Intro Lecture (Hx) Flashcards
Curare
muscle relaxant
ether
surgical anesthetic
_________ is a local anesthetic similar to morphine
cocaine
____ offsets the effects of curare
nicotine
_____ kills bacterial cells without harming human cells
penicillin
____ aka diphenylhydantonin allowed epileptics to live normal lives
dilantin
Pure food and drug act was initiated in the year _____ and it’s purpose was___
1906; regulate products manufactured domestically… make sure their claims of purity, strength, and quality were correct.
Shirley amendment was instituted in ____, and did ___
prohibited false claims of therapeutic effects (they must do what they claim to do)
In ____(yr) a new wonder drug called ____ was dissolved in diethylene glycol (commonly known as ____) and killed at least 100 ppl … This resulted in the formation of the _____
1938, sulfanilamide, antifreeze; FDA
In ______(yr) the FDA was formed to enforce the ______act
food, drug, and cosmetic act - evaluate clinical trials, safety, quality.
The food, drug, and cosmetic act required that products be _______ but not _______
safe for human use, but not effective
In _____(yr), ______ was used as a sedative and lead to limb related birth defects
1960; thalidomide
The use of Thalidomide lead to the passage of the _______ amendment in _______ that required ______
Kefauver-harrison amendment is 1962, required drugs be safe AND effective
OTC/non-prescription VS. Hazardous/Prescription
OTC: deemed safe enough for ppl to self-treat; Prescript: drugs only useful after professional diagnosis or too dnagerous for self medication
The ______act in ________ lead to the DEA administering drugs and the classification of different “schedules/classes” of drugs
comprehensive drug abuse prevention and control act in 1970
CI drugs differ from CII-V in that they are said to have __
no accepted medical use
CI drugs have a _____potential for abuse and include drugs such as _______ & _________
High (the highest potential); heroin and LSD
CI &CII are said to cause _______ psychological/physiologic dependence
Severe
CV and CIV have a ____ potential for abuse and cause _______ psychological/physiologic dependence
low (CV is the lowest), cause limited dependence
Name the schedule of the following drugs: Morphine & Oxycodone, codeine, diphenyloxylate, diazepam
CII, CIII, CV, CIV
In ____ the FDA passed the _____ act to incentivize companies to make drugs that stood to provide less profit (ie pediatric, AIDS, Alzheimers drugs)
1997 FDA modernization act
Preformation Vs formulation Vs preclinical studies
Preform: define phys and chem properties; formulation: develop product/dosage; preclinical: cell culture and animal studies for effectiveness and safety
What is the population, size, length, and purpose of phase 1 trials
<100 HEALTHY volunteers, over several months to eval SAFETY (not efficacy)
What is the population, size, length, and purpose of phase 2 trials
up to several hundo ppl w/condition, several mo - 2 yrs, eval mainly efficacy
