Lecture 1 Flashcards
What act was passed in 1906 and stated that medications had to be safe.
Pure Food and Drug Act
What schedule drug has no accepted medical use and highest potential for abuse?
CI
What schedule drug has an accepted medical use and has high potential for abuse. Physical and psychological dependence is high.
CII
What year was the FDA created?
1938
Why was the Kefauver-Harris Amendment passed ? When?
Limb defects from Thalidomide. Passed in 1962
What Act was passed in 1997 made it easier for a generic drug to come to market?
Food and Drug Administration Modernization Act
How many classes are there of controlled substances?
5
What is a proprietary Drug Name?
Patented exclusive property of a drug manufacturer.
What is a generic name?
Only one name for each drug. Selected and internationally recognized.
What is the difference b/w OTC and prescription drugs?
OTC is deemed safe enough for a layperson to use in self treatment where a prescription is only considered useful after an expert diagnosis.
How many phases of drug development are there?
5 Preclinical Phase 1 Phase 2 Phase 3 Phase 4- post marketing surveillance
Which phase uses up to a several hundred patients and mainly tests effectiveness?
Phase 2
What phase uses healthy volunteers and is for safety?
Phase 1
What phase lasts 1-4 years and tests safety, effectiveness, dosages and uses hundreds to thousands of subjects?
Phase 3
When is a DEA number required?
CII prescriptions
